Recall Z-1178-2023— Covidien, LP

Name: FDA recall Z-1178-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2022-12-02. It names one FDA 510(k) clearance: K981582. Product: Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12. Reason: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2022-12-02
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K981582 — SURGILON, DERMALON, & OPHTHALONDavis & Geck, Inc.·cleared 1998-07-13

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

Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12

Reason for recall

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

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