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***"
FDA Recall Z-2252-2013 · Posted 2013-09-18
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Recalling FirmChurchill Medical Systems, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-08-12
Date Terminated2014-06-16
Product Quantity3040
Reason for Recall
Microbore tubing disconnecting from male luers on the extension sets.
Firm Action
"Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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