3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.

FDA device recall Z-1413-2010 · posted 2010-04-20 · Terminated

Recall details

Recalling firm

3M Company / Medical Division

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KGX

Quantity affected

165,826 boxes, 100 rolls per box (16,582,600 rolls)

Distribution

Nationwide distribution, and Puerto Rico.

Date initiated

2010-01-29

Date posted

2010-04-20

Date terminated

2012-02-04

Location

Saint Paul, MN