Agency classClass IOur severity:Severe FDA (Devices)·Z-1049-2014·Announced 2014-03-05

Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect

Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).

Plain-English summary

Medline Industries, Inc. is recalling 120 units of the Cath Lab Custom Pack (Reference: DYNJ40926). These surgical kits are used to supply tools required to perform angiography medical procedures. The recall is due to a potential defect in the Guidewire .035x150 3MMJ TCFC (item number 88241) included in the kits, where the coating has the potential to flake off the wire.

The affected product is identified by Pack Number DYNJ40926 and Lot 13FB4759. The kits were packaged in Mexico by Medline Industries, Inc., located in Mundelein, IL. The recall is classified as Class I by the FDA.

The product was distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. Consumers and healthcare facilities should stop using the affected kits and contact Medline Industries at 1-800-Medline or visit www.medline.com for further instructions.

The recalled product

Product: CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Manufacturer: Medline Industries, Inc.
Category: Medical Device — Surgical Kits
Hazard: coating-flaking
foreign-object
Affected units: 120

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)

Pack Number: DYNJ40926
Lot: 13FB4759

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 11 recalled by Medline Industries, 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 11 products in this recall →

Same manufacturer · Medline Industries, Inc.

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Same hazard · coating flaking