Home / Recalls / Churchill Medical Systems, Inc. / Z-2252-2013

Z-2252-2013 Class II Terminated

Recalled by Churchill Medical Systems, Inc. — Dover, NH

FDA device recall Z-2252-2013 was initiated by Churchill Medical Systems, Inc. on August 12, 2013 and is designated Class II. Reason for recall: Microbore tubing disconnecting from male luers on the extension sets. The recall status is terminated (terminated June 16, 2014). Affected quantity: 3040.

Recall Details

Product Type: Devices
Report Date: September 25, 2013
Initiation Date: August 12, 2013
Termination Date: June 16, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3040

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***"

Reason for Recall

Microbore tubing disconnecting from male luers on the extension sets.

Distribution Pattern

Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

Code Information

Lot Numbers: 1303022, 1304065

Other recalls by Churchill Medical Systems, Inc.

Z-1472-2015 Class II — 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to adminis (January 15, 2015)
Z-1467-2015 Class II — 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to (January 15, 2015)
Z-1477-2015 Class II — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and (January 15, 2015)
Z-1476-2015 Class II — Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accesso (January 15, 2015)
Z-1469-2015 Class II — 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory de (January 15, 2015)
Z-1473-2015 Class II — 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Access (January 15, 2015)
Z-1470-2015 Class II — 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to (January 15, 2015)
Z-1468-2015 Class II — Bifircated Extension Set, Product Code: BN-828 Accessory device used to adminis (January 15, 2015)
Z-1478-2015 Class II — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used (January 15, 2015)
Z-1474-2015 Class II — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device (January 15, 2015)