Covidien Dermalon sutures recalled over sterile packaging breach
Covidien is recalling certain Dermalon 4-0 blue 75cm sutures because the sterile packaging may be torn or perforated. This could allow germs into the sutures, which may lead to infection, vision loss in eye surgery, or longer surgeries. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Covidien recalls
What to do
- Check whether your facility has Dermalon sutures with lot numbers D6A3020FY or D6A2861FY.
- Do not use affected sutures in patient care.
- Contact Covidien or your supplier for return or replacement instructions, since the notice lists no specific remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
- 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-2920-2026
In the FDA's words
- Description
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 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. 88861757-31 UDI-DI 10884521070912 Lot D6A3020FY UDI-DI 20884521070919 Lot D6A3020FY 88861799-31 UDI-DI 20884521071060 Lot D6A2861FY 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.
- 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 C…Z-2918-2026 · 135,875 total
- V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056…Z-2919-2026 · 135,875 total
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 (this page)Z-2920-2026 · 135,875 total
- Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Z-2921-2026 · 135,875 total
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXZ-2922-2026 · 135,875 total