The Recall Desk
HighFDA (Devices)·Z-2252-2013·Announced 2013-09-25

Churchill Medical Systems Recalls Central Dressing Change Kits

Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect (tubing disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Churchill Medical Systems, Inc. is recalling 3,040 units of the Central Dressing Change Kit (Lot Numbers 1303022, 1304065). The recall is due to a defect where microbore tubing may disconnect from male luers on the extension sets included in the kit.

The affected kits were distributed nationwide, including in New York, Minnesota, New Jersey, Pennsylvania, Florida, Maryland, and Virginia. The kits contain various medical supplies, including nitrile gloves, face masks, drapes, and extension sets.

Consumers and healthcare facilities should stop using the affected kits and contact Churchill Medical Systems for further instructions or a replacement.

The recalled product

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/Bionecto
Manufacturer
Churchill Medical Systems, Inc.
Category
Medical Device — Dressing Change Kit
Hazard
Affected units
3,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: 1303022
  • 1304065

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Churchill Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Churchill Medical Systems, Inc.

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Same hazard · tubing disconnection

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