Churchill Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2252-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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***"

Product Classification:

Class II

Date Initiated: August 12, 2013

Date Posted: September 25, 2013

Recall Number: Z-2252-2013

Event ID: 66060

Reason for Recall:

Microbore tubing disconnecting from male luers on the extension sets.

Status: Terminated

Product Quantity: 3040

Code Information:

Lot Numbers: 1303022, 1304065

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated