The Recall Desk
HighFDA (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.

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 with a potential for coating flaking, which poses a risk of harm to patients during surgical procedures, but the source text does not report any specific injuries or illnesses.

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
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 →

Related recalls

Same manufacturer · Medline Industries, Inc.

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Same hazard · coating flaking

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