Recall Z-0772-2023— TELEFLEX LLC

Name: FDA recall Z-0772-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX LLC, initiated 2022-09-28. It names one FDA 510(k) clearance: K791871. Product: Pilling Wecksorb Cylindrical Sponges. Reason: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised..

Recalling firm: TELEFLEX LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K791871 — NEUROLOGICAL SPONGES (PATTIES)Carwild Corp.·cleared 1979-11-05

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

Pilling Wecksorb Cylindrical Sponges

Reason for recall

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

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