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Moderate riskFDA DeviceClass II

Covidien V-Loc 90 sutures recalled for sterile packaging breach

Covidien is recalling certain V-Loc 90 absorbable wound closure devices, which are surgical sutures. The sterile packaging on some units may have a tear or hole, which could allow the sutures to become contaminated with germs. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Covidien recalls

What to do

  1. Check product names, model numbers, and lot numbers against the recall list if you work in or receive care at a facility that uses these sutures.
  2. Do not use affected units if you find them; contact the facility or manufacturer for guidance.
  3. Ask your healthcare provider if you have questions about a procedure that may have used these sutures.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
135,875 total
Illnesses reported
None reported
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Classification
Class II
Recall number
Z-2918-2026

In the FDA's words

Description
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115 Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. VLOCM0336 UDI-DI 20884521132501 Lot A5M0917VY VLOCM0436 UDI-DI 20884521827513 Lot A5M1035VY VLOCM0003 UDI-DI 10884521131606 Lot A5M1022VFY UDI-DI 20884521131603 Lots A5M1022VFY A5M1166VFY VLOCM0013 UDI-DI 10884521131644 Lot A5M1024VFY UDI-DI 20884521131641 Lots A5M1023VFY A5M1024VFY VLOCM0024 UDI-DI 10884521131699 Lot A5M0860VFY UDI-DI 20884521131696 Lot A5M0860VFY VLOCM0123 UDI-DI 20884521132235 Lot A5M1169VFY VLOCM0315 UDI-DI 20884521132464 Lot A6A1005VY VLOCM0603 UDI-DI 10884521132535 Lot A5M1246VY UDI-DI 20884521132532 Lot A5M1246VY VLOCM0604 UDI-DI 10884521132542 Lot A5M1062VY UDI-DI 20884521132549 Lots A5M1014VY A5M1062VY VLOCM1203 UDI-DI 10884521132757 Lot A6A1063VY UDI-DI 20884521132754 Lot A6A1063VY VLOCM2115 UDI-DI 20884521133003 Lot A5M1155VY Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan. Affected quantity: 135,875 total
Hazard
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

5 products in this recall

Covidien surgical sutures recalled for compromised sterile packaging

Covidien is recalling five surgical suture products, including V-Loc 90, V-Loc 180, Dermalon, Surgipro and Surgipro II, with about 135,875 units affected. The sterile packaging may have a tear or hole, which could let germs reach the sutures and cause infection, prolonged surgery, or vision loss if used in eye surgery. The recall covers the US and many other countries, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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