RECALL REPORTING INSTRUCTIONS

and

RECALL REPORT FORM

This form may be used to provide Food and Drug Administration (FDA) in gathering voluntary recall information and documents for the FDA Recall Coordinator from a recalling firm and/or manufacturer.

Please provide detail information regarding the recall (please follow the number format below, and do NOT use phrase as "see attached" or "refer to," instead, please describe it in detail):

1.   PRODUCT(S):  IF THE PRODUCT IS A MEDICAL DEVICE, INCLUDE:

a. Name of device (If recalled product is software: include version number; if a device component: list what the product is a component of.):   Odatus Portable Units

b. Model Number(s): Numerous Numbers by mfg Dates.

c. Distributed by and/or Manufactured by (Care Tech Industries, Inc.):

d. Provide Product Indication (A brief description of the product and its use.):
These units are air cleaners used to purify the air.

e. Provide 510(k) number(s) and date:  NONE GIVEN

f. FDA Registration Number ( 3004905773): 

g. Shelf Life: N/A

h.Expiration date: (if any): N/A

i. Date(s) of manufacture (e.g. 12/15/00 to 03/30/00): 1990 to 10/2007

j.  Is the device labeled as STERILE?        YES [  ]  NO  [ X ]

k.  Is the device SOFTWARE controlled?  YES [  ]  NO  [ X ]

1. N/A PRODUCT(S):  IF THE PRODUCT IS A FOOD, BEVERAGE, ETC., INCLUDE

Name of product:

Brand name:

Unit size (1/2 gallon, 18 ounce, 2 lb. pkgs.):

Container description (in paper cartons, in glass jars ):

Total package size (12 packages per case):

f.   Distributed by and/or Manufactured by (ABC Co. San Francisco, CA):

Storage instructions, if any (frozen, refrigerate after opening etc.):

FDA Registration Number, if any (29xxxxx):

1. N/A PRODUCT(S):  IF THE PRODUCT IS A HUMAN DRUG, INCLUDE:

Name:

Brand name:

NDC# and/or NDA/ANDA#:

Type or form (tablets, capsule, liquid, etc.):

Strength per dose, dosage:

State Rx or OTC:

Provide Product Indication (A brief description of the product and its use.):

N/A IF THE PRODUCT IS A BIOLOGIC, INCLUDE: name, label, laboratory test results, patient data card (you may purge personal identifying data, such as name, social security number, address).

N/A IF THE PRODUCT IS A DIETARY OR FOOD SUPPLEMENT, INCLUDE:  name, brand name type or form (tablets, capsule, liquid, etc.); strength per dose, dosage, a brief description of the product and its use (if any).

1.N/A PRODUCT(S):  IF THE PRODUCT IS A COSMETIC, INCLUDE: name, brand name type or form (capsule, liquid, etc.); a brief description of the product and its use (if any).

1. N/A  PRODUCT(S):  IF THE PRODUCT IS A CERAMIC, OR OTHER FOOD RELATED ARTICLE INCLUDE: name, brand name, generalized description of design, diameter and/or dimensions of bowls, plates, etc.

N/A PRODUCT(S):  IF THE PRODUCT IS A VETERINARY DRUG OR FEED OR FEED ADDITIVE, INCLUDE:

a    Name:

Brand name:

NDC# and/or NDA/ANDA#:

Type or form (tablets, capsule, liquid, etc.):

Strength per dose, dosage:

State Rx or OTC:

Provide Product Indication (A brief description of the product and its use.);

                                                  (State if product is a drug or a feed additive.):

2.   CODE:

List all batch numbers, lot numbers and/or serial numbers, product numbers, catalog numbers, packer or manufacturer numbers, pull date (exp. date), etc.

3a.   RECALLING FIRM:

Provide complete name and address of your firm.  (Please include full name, full address, telephone and telefax number.)
Care Tech Industries, Inc.
8976 Seminole Blvd.
Seminole, FL. 33772
727-393-3327

3b.   MANUFACTURER:

Provide complete name and address of manufacturer, if different from recalling firm.  (Please include full name, full address, telephone and telefax number.) N/A

4.   REASON FOR RECALL:

a.  State simply WHY your firm decided to recall the product(s). We did not decide. The FDA threat letter dated 4/28/08 of "failure of corrections" encouraged this recall.

b.  How did your firm DISCOVER THE REASON for recall [problem description]?

What is the ROOT CAUSE of the reason for recall? NONE

(Provide copies of  Engineering Failure Analysis/Failure Investigation (or equivalent), test results/lab. results, methodology used, if any.)

  What is the ROOT CAUSE of the reason for recall? NONE

(Include any analytical finding in qualitative and/or quantitative terms, indicating whether your firm's analysis or private laboratory was involved.  Provide copies of test results/lab. results, Analytical Work Sheets, methodology used, if any.)

c.  Is the root cause of the problem related to:

(i)  STERILITY deficiency      :  YES [  ]  NO  [ X ]

(ii)  PACKAGING deficiency:  YES [  ]  NO  [ X ]

d.  What type of ILLNESS or INJURY may be caused by the problem?
We are not doctors or qualified to answer this question. Our opinion? No scientific evidence was ever found to our knowledge and research..

e.  What is the TOTAL number of reports of ILLNESS or INJURY COMPLAINTS received

         regarding recall product?

(Please provide copies of such report.) NONE

f. MDR COMPLAINTS (either filed or not filed with the FDA):

            [If no MDR complaints, state 0 (zero)] 0

Number of deaths             :__________

Number of injuries            :__________

Number of Malfunctions:__________

Additional MDR comments (if any):

What is the TOTAL number of reports of PRODUCT DEFECT COMPLAINTS received

            regarding the recall product?

(Please provide copies of such report.) NONE

Have you done any HEALTH HAZARD EVALUATIONS and/or Health Risk Assessments

            associated with the recall product? NO

(No health consequences, minor/major health consequences, potential serious risk of patient injury, potential risk of a serious or life threatening allergic reaction/DEATH!)

i.   List corrective measures taken to PREVENT SIMILAR OCCURRENCE of the problem. NONE

(Include copies of documents pertaining to Engineering Change Orders (devices), verification of training or SOP changes, documents pertaining to product QA, design control, specifications, validation of software, etc., as appropriate.)

5.   VOLUME OF PRODUCT IN COMMERCE:

a.  What is the TOTAL amount of recall product that was manufactured? 316

b.  What is the TOTAL amount of recall product distributed in commerce? 316

c.  What is the TOTAL amount of recall product remaining at your firm? NONE

What were the DATES of distribution? 11/9/04 to 725/07

                        (e.g. 12/14/99 to 2/15/00)

e.  Provide an ESTIMATE (%) of the amount of product that may be recovered. 0

6.   DISTRIBUTION PATTERN:

What is the TOTAL number of consignees (all customers) that received the recall product? 0

            (6b+6c+6d, see below)

b.  What is the TOTAL number of wholesaler dealers that received the recall product? 0

c.  What is the TOTAL number of distributors that received the recall product? 0

d.  What is the TOTAL number of retailers that received the recall product? 0

e.  What is the TOTAL number of consumers/users that received the recall product? 316

f.  Where is the recall product distributed?

     (Indicate worldwide/nationwide/statewide and name the U.S. States, e.g., CA, NV,)

     (Provide a list of the U.S. consignees with their FULL ADDRESSES with PHONE NUMBERS via overnight express.) 0

g.  Where there any product distributed to Defense Supply Center, VA or other Federal Government sales/distribution centers?  0

 (Provide List of foreign/military/government consignees in a separate list with full addresses

  via overnight express.) 0

7.   FIRM'S RECALL STRATEGY:

Following questions are provided to assist you in describing your recall strategy in DETAIL as follows:

 Include the DATE recall was initiated, if it is already underway or the DATE your firm

            plans to start the recalling process.  5/4/08

(b)  How do you plan to NOTIFY all the consignees affected by this recall?

            (press release, letter, telefax, telephone, e-mail, visit, etc.) Internet & Letter

(c) How do you plan to undertake a SUB-RECALL?  (If the product is distributed to wholesale dealers/distributors/retailers) N/A

(provide follow-up letters to wholesalers, e.g., wholesalers are requested to forward copies of your recall letters and response forms to their customers, etc.) N/A

How do you plan to monitor the number of consignees NON-RESPONDING to the recall communication?

(include envelopes and return/reply cards, via response form mailed, certified mailing with return  receipt, visit, telephone follow-up call, etc.) N/A

(e)  How do you plan to do EFFECTIVENESS CHECKS of this recall?

(by response form mailed?, certified mailing with return receipt, etc.)

(telefax, telephone, e-mail, visit, follow-up letter, etc.) Telephone follow-up calls.

(f)  Date your firm ceased further distribution of the product(s). 7/07

(g)  How do you plan to STORE the recall product? (if returned) Correct label

(quarantine, locked stored, etc.)

[NOTE:  It is equally important to assure that all returned merchandise is promptly inventoried, handled, and stored in such a manner as to assure its separation from acceptable materials so it will not inadvertently be used or shipped.  Our past experience in similar situations has shown that the longer a defective product is held between the initiation and termination of a recall, the greater the chance of its accidental misuse.]

(h)  How do you plan to DISPOSE the recall products? Correct label

(destroy, recondition, correct label, field correct by firm's personnel, etc.)

Please Note:  Any destruction or reconditioning of recalled items may require FDA supervision.

8.   FIRM OFFICIAL:

Name of the most responsible individual (with title) to contact regarding the recall.

Please include full address, telephone and telefax number.

9.   PRESIDENT OF THE FIRM:

Please include full name, full address, telephone and telefax number.

Please address all your correspondence regarding this matter to:

Leroy Terrelonge

Recall and Emergency Coordinator

U.S. Food and Drug Administration

Florida District Office

555 Winderley Place Ste 200

Maitland, FL 32751

Leroy.terrelonge@fda.hhs.gov

Telephone  (407) 475-4717

Telefax       (407) 475-4768

PLEASE PROVIDE THE FOLLOWING DOCUMENTS:

PRODUCT LABEL(s):         (Label(s) and labeling(s);

CUSTOMER LETTER(s):   (Notification letter(s) to consignees, recall letter(s)

Voluntary or recall letter(s);

DISTRIBUTION LIST:        (List of consignees or list of customers, INCLUDE FULL

STREET ADDRESSES with PHONE NUMBERS);

PRODUCT CATALOG         (if any);

TEST RESULT(s):                (Analytical Work Sheet, Failure Analysis Worksheet, Lab.

results, etc. and methodology used);

DOCUMENT(s):                   (Health Risk Assessment, Product QA, Specification Sheet, SOP changes, etc); and

PRESS RELEASE:                (News release, allergy alert, if any).

TO EXPEDITE THE RECALL PROCESS YOU MAY CHOOSE TO E-MAIL THE ABOVE INFORMATION TO ME AT Leroy.terrelonge@fda.hhs.gov

AND MAIL VIA OVERNIGHT EXPRESS THE RESPECTIVE DOCUMENTS.

Thank you Mr. Terrelong, for your cooperation and efforts.

John O. Shannon, President
Care Tech Industries, Inc.
727-393-3327