Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
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: Class II medical device recall with potential for non-sterility but no reported illnesses or injuries. The hazard is theoretical, limiting the score to 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries has recalled certain Pediatric Drape PK kits (REF DYNJ81297) that were packaged in breather pouches with lot number 323080002. These medical procedure convenience kits are intended for use in healthcare settings.
The recall was issued because the breather pouches may allow non-sterile product use if the vendor seal is opened or compromised. Sterility is critical for medical devices used in patient care procedures.
The affected units were distributed worldwide to the United States (nationwide), Canada, and Panama. Healthcare facilities that have received these kits should verify the affected lot number and contact Medline Industries for further instructions regarding replacement or return of the recalled product.
The recalled product
- Product
- Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 150
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)
- UDI/DI 40195327108084 (each)
- 10195327108083 (case)
- Lot Numbers: 23LBL738
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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