Recall Z-1610-2023— 3M Company - Health Care Business

Name: FDA recall Z-1610-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-06

Class II · Ongoing

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2023-04-06. It names one FDA 510(k) clearance: K220942. Product: 3M Attest Steam Chemical Integrators, REF 1243B. Reason: 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Ongoing
Initiated: 2023-04-06
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K220942 — 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company·cleared 2022-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

3M Attest Steam Chemical Integrators, REF 1243B

Reason for recall

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.