Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0937-2013·Announced 2013-03-20

Vygon Recalls 210 CT PICC Kits Packaged with Incorrect Needles

Vygon Corporation is recalling 210 units of 6F Triple Lumen CT PICC kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a packaging/labeling discrepancy where a non-safety needle was used instead of a safety needle. No injuries or illnesses are reported in the source text, and the hazard is primarily related to the lack of a safety feature rather than a direct contamination or structural failure.

Plain-English summary

Vygon Corporation is recalling 210 units of Churchill Medical Systems, Inc. 6F Triple Lumen CT PICC with M.S.T. Components. The recall involves all sizes of the CMS-CT6T225 model. The product was distributed to four hospitals within one hospital network in Pennsylvania.

The recall was initiated because the kits were packaged with the incorrect introducer needle. While the kit label indicates that a "safety" needle is included, the affected kits were packaged with a non-safety needle. The affected lot numbers are MBKQ640, MBKZ720, MBLJ290, MBLR100, MBLZ350, and MBMG250, with expiration dates ranging from May 2015 to October 2015.

This recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, but the product was distributed to specific hospital facilities.

The recalled product

Product: Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Manufacturer: Vygon Corporation
Category: Medical Device — Catheters
Hazard: mis-labeling
packaging-error
Affected units: 210

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 (11)

Lots numbers MBKQ640
exp 05/2015
MBKZ720
MBLJ290
exp 06/2015
MBLR100
exp 07/2015
MBLZ350
exp 09/2015
and MBMG250
exp 10/2015.

Distribution

Distributed in 1 state:

Same manufacturer · Vygon Corporation

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Same hazard · mis labeling