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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description 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***"
Recall Number Z-2252-2013
Classification Class II
Code Info Lot Numbers: 1303022, 1304065
Product Distributed Qty 3040
Reason For Recall Microbore tubing disconnecting from male luers on the extension sets.

Event Detail

Event Id 66060
Product Type Devices
Status Ongoing
Recalling Firm Churchill Medical Systems, Inc.
City Dover
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-12
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.