Recall Z-1172-2023
Covidien, LP · initiated December 2, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: GTIN: 10884521070981 20884521070988 20884521070797 10884521070790 20884521070797 20884521070698 10884521070691 20884521070834 10884521070806 20884521070803 20884521070698 10884521070691 20884521070797 Lot # (1) D2B0701Y, D2E3000Y (2) D1M2315FY, D1M2326FY,D2F1873FY (3) D2B2781FY (4) D2B1309FY (5) D1J0777FY
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
FDA-determined cause: Packaging process control
Action taken
Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to rs.gmbfcamitg@medtronic.com.> " Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below. " Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. Shipping and Return Instructions: " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit or Replacement for the returned affected product will be issued based on the RGA number. " Return all unused and non-expired affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
Details
- Recall number
- Z-1172-2023
- Initiated
- December 2, 2022
- Posted by FDA
- February 25, 2023
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Quantity
- 9606
- Distribution
- US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN…
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1173-2023 Class II | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1174-2023 Class II | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1175-2023 Class II | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1176-2023 Class II | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1177-2023 Class II | Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1178-2023 Class II | Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1179-2023 Class II | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1180-2023 Class II | Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1181-2023 Class II | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1182-2023 Class II | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |