Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0898-2013·Announced 2013-03-06

MedComp Recalls 785 PICC Kits Packaged with Incorrect Needles

Medical Components, Inc. is recalling 785 power injectable infusion PICC insertion 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 the source text describes a packaging and labeling discrepancy (incorrect needle type) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medical Components, Inc. dba MedComp is recalling 785 units of REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components. These products are power injectable infusion PICC insertion kits. The affected lots are MBKQ640, MBKZ720, MBLJ290, MBLR100, MBLZ350, and MBMG250, with expiration dates ranging from May 2015 to October 2015.

The recall was initiated because the affected products were packaged with the incorrect introducer needle. While the kit label indicates that a "safety" needle is included, the kits were actually packaged with a non-safety needle. This discrepancy represents a labeling and packaging error regarding the specific components provided in the kit.

The products were distributed nationwide in the United States, including the state of Pennsylvania. The source text does not report any illnesses or injuries associated with this recall. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates and contact the manufacturer or their supplier for instructions on how to return or dispose of the affected kits.

The recalled product

Product: REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Manufacturer: Medical Components, Inc dba MedComp
Category: Medical Device — Infusion Kits
Hazard: mis-labeling
packaging-error
Affected units: 785

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 nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Medical Components, Inc dba MedComp

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