Churchill Medical Systems, Inc.: Microbore tubing disconnecting from male luers on the extension sets.

Agency Publication Date: September 18, 2013

Affected Products

Product: 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

Product: 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

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66060

Status: Resolved

Manufacturer: Churchill Medical Systems, Inc.

Manufactured In: United States

Units Affected: 2 products (13100; 3040)

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Sources: FDA iRES · Raw API Response

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