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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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***" Lot Numbers: 1303022, 1304065 Class II Microbore tubing disconnecting from male luers on the extension sets. 3040 Z-2252-2013
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. 1203117, 1206030, 1212111, 1304133, 130516 Class II Microbore tubing disconnecting from male luers on the extension sets. 13100 Z-2251-2013
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