Hazard description
On 29-Jan-2026 during a quality inspection at a manufacturing site, a V-Loc 180 unit was found with a hole in the breather pouch on the Tyvek side. The breather pouch serves as the sterile barrier system for the suture. Investigation determined the briller plate on the sealing station may be causing the hole. No complaints have been identified for this issue, but lots within the issue bounding have been released to Distribution Centers (DCs) and sold to customers. These released lots may also contain units with holes in the Tyvek side of the breather pouch.
RecallTracker