FDAFDA · Food and drugs·Recall number Z-2252-2013
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"
Published September 25, 2013 · Recall initiated: August 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbore tubing disconnecting from male luers on the extension sets.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Churchill Medical Systems, Inc.
- Distributor
- Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
- Lot
- Lot Numbers: 1303022, 1304065
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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