Z-1416-2010

3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case

Name: Z-1416-2010 3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case
Creator: 3M Company / Medical Division
Published: 2010-01-29
License: https://open.fda.gov/license/

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

FDA source

3M Company / Medical Division began a recall of 3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case on 2010-01-29. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1416-2010
Status: Terminated
Initiated: 2010-01-29
Posted: 2010-04-20
Terminated: 2012-02-04
Recalling firm: 3M Company
Product: 3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 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: 2,664,800
Distribution: Nationwide distribution, and Puerto Rico.
Product codes and lots: 200901XI 200903XH 200904BK 200904YR 200906ER 200909CC 200909ES 200911NM 200911OJ 200902XH 200902XI 200902XU 200903YR 200904CA 200909EU 200812TR 200911FZ

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)