The Recall Desk
HighFDA (Devices)·Z-1047-2014·Announced 2014-03-05

Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect

Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component 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 that could compromise the integrity of the guidewire during a surgical procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, Inc. is recalling 768 units of Angio Pack #2 surgical kits, reference number DYNJ39185. These 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 a potential to flake off of the wire.

The affected lots are 13EB2046, 13FB1553, and 13GB2605. The product was packaged in Mexico by Medline Industries, Inc., located in Mundelein, IL. The kits were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia.

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

The recalled product

Product
ANGIO PACK #2; REF: DYNJ39185; 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
768

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 (4)

  • Pack Number: DYNJ39185
  • Lots: 13EB2046
  • 13FB1553
  • 13GB2605

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 →

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Same manufacturer · Medline Industries, Inc.

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Same hazard · coating defect

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