Recall Z-1172-2023— Covidien, LP
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: Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13. 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 recordK-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
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
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.