The Recall Desk
HighFDA (Devices)·Z-1055-2014·Announced 2014-03-05

Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect

Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.

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 defect (coating flaking) that poses a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, Inc. is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS (Reference: DYNJ40851). These surgical kits are used to supply tools required to perform 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 a potential to flake off of the wire.

The affected products were packaged in Mexico for Medline Industries, Inc. in Mundelein, IL. The specific lot number is 13FB8753. The products were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia.

Healthcare facilities and consumers should stop using the affected drape packs and contact Medline Industries at 1-800-Medline or visit www.medline.com for further instructions.

The recalled product

Product
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Manufacturer
Medline Industries, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
50

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: DYNJ40851
  • Lot: 13FB8753

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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