Medline Thyroid Pack Recall Due to Non-X-Ray Detectable Sponge
Medline Industries is recalling 40 Thyroid Pack CKHA-LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only to 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 (non-x-ray detectable sponge) that poses a risk of harm (retained foreign body) in a high-risk setting (surgery), 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 40 units of the Thyroid Pack CKHA-LF, Model DYNJ50352B. This product is a convenience kit used in various surgeries, including cardiac, abdominal, and neck surgeries. The recall is being issued because the cylindrical sponge component included in the kit is not x-ray detectable.
The affected lots are 20HBM370 (Expiration 02/28/2025), 20IBB678 (Expiration 03/31/2025), and 20KBP338 (Expiration Date: 05/31/2025). The source text notes that lot 20KBP338 was never distributed. The distribution pattern for this recall is foreign distribution only, specifically to Canada.
Healthcare providers and facilities that have received these products should stop using them and contact Medline Industries Inc for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Thyroid Pack CKHA-LF, Model DYNJ50352B - 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
- Affected units
- 40
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 20HBM370 (Expiration 02/28/2025)
- 20IBB678 (Expiration 03/31/2025)
- 20KBP338 (Expiration Date: 05/31/2025 never distributed)
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.
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