Z-2252-2013Class II

Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves...

Name: Z-2252-2013 Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves...
Creator: Churchill Medical Systems, Inc.
Published: 2013-08-12
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2013-08-12 / Terminated

FDA source

Churchill Medical Systems, Inc. began a recall of 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... on 2013-08-12. FDA classified it as Class II and gives the reason as "Microbore tubing disconnecting from male luers on the extension sets". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2252-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-09-18
Terminated: 2014-06-16
Recalling firm: Vygon Mfg
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***"
Product code: FPA Set, Administration, Intravascular
Reason for recall: Microbore tubing disconnecting from male luers on the extension sets.
FDA root cause: Under Investigation by firm
Action: "Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414.
Quantity in commerce: 3040
Distribution: Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Product codes and lots: Lot Numbers: 1303022, 1304065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2251-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2252-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18

Product code FPA

K963981Class IIVygon Bionector with Extension SetVygon Corp. / cleared 1997-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)