The Recall Desk
HighFDA (Devices)·Z-0783-2021·Announced 2021-01-13

Medline Cardiac Pack Recall for Non-X-Ray Detectable Sponge Component

Medline Industries is recalling Cardiac Pack - LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only in Canada.

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

Plain-English summary

Medline Industries Inc is recalling 360 units of Cardiac Pack - LF, Model DYNJ31903I. These convenience kits are used in various surgeries, including cardiac, abdominal, and neck surgeries. The recall is due to a defect where the cylindrical sponge component is not x-ray detectable.

The affected lots are 20GBG768 (Expiration: 11/30/2021), 20HBO067 (Expiration: 02/28/2022), and 20IBC642 (Expiration: 03/31/2022). The distribution pattern for these units was foreign distribution only, specifically to Canada.

Healthcare facilities and consumers who have these specific lots should stop using the product and contact Medline Industries Inc for further instructions. The lack of x-ray detectability poses a risk if the sponge is inadvertently left inside a patient during surgery, as it may not be easily identified via imaging.

The recalled product

Product
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Manufacturer
Medline Industries Inc
Category
Medical Device — Surgical Kits
Hazard
Affected units
360

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 (3)

  • Lot 20GBG768 (Expiration: 11/30/2021)
  • 20HBO067 (Expiration: 02/28/2022)
  • Lot 20IBC642 (Expiration 03/31/2022)

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Medline Industries Inc

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Same hazard · retained foreign object

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