Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1420-2010

3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case

3M Company / initiated 2010-01-29 / Terminated / root cause: manufacturing process

3M Company / Medical Division began a recall of 3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case on . The reason FDA records is "Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1420-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
3M Company
Product
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
Product code
KGX Tape And Bandage, Adhesive
Reason for recall
Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 yard rolls (CAT #1530-1) as a substitutio
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Quantity in commerce
15,360 rolls
Distribution
Nationwide distribution, and Puerto Rico.
Product codes and lots
200902YK 200903AR 200904YR 200908JY 200909LA 200912OU 201001RN