Recall Z-1199-2023— Beaver Visitec International, Inc.

Name: FDA recall Z-1199-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-20

Class II · Ongoing

Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2022-12-20. It names one FDA 510(k) clearance: K920354. Product: Ultracell Wick with 80cc Collection Bag, 20/box. Reason: Device packaging may contain open seals, compromising product sterility..

Recalling firm: Beaver Visitec International, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-20
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K920354 — OPHTHALMIC SPONGESUltracell Medical Technologies, Inc.·cleared 1992-08-05

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

Ultracell Wick with 80cc Collection Bag, 20/box

Reason for recall

Device packaging may contain open seals, compromising product sterility.

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