Recall Z-1181-2023— Covidien, LP

Name: FDA recall Z-1181-2023
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: K990952. Product: Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA. 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

K990952 — NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURESUnited States Surgical, A Division of Tyco Healthc·cleared 1999-04-01

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

Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA

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.