Agency classClass IOur severity:Severe FDA (Devices)·Z-1048-2014·Announced 2014-03-05

Medline Recalls Heart Catheter Kits Due to Coating Defect

Medline Industries is recalling 160 Heart Cath Custom Packs because a guidewire component may have a flaking coating.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc."

Plain-English summary

Medline Industries, Inc. is recalling 160 units of the HEART CATH CUSTOM PACK (Ref: DYNJ39747A). 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. The coating on the guidewire has a potential to flake off. The affected lots are 13EB2095, 13EB3153, 13FB4157, 13RB0832, and 13GB2692.

The affected products were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. Healthcare facilities and consumers should stop using these specific kits and contact Medline Industries for instructions on returning the product.

The recalled product

Product: HEART CATH CUSTOM PACK; REF: DYNJ39747A; 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: 160

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 (6)

Pack Number: DYNJ39747A
Lots: 13EB2095
13EB3153
13FB4157
13RB0832
13GB2692

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