Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of Convenience Kits because calibration problems with sterilization and packaging equipment may have compromised the sterility of the products.
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: This is an FDA Class II medical device recall involving sterilization integrity issues that pose a potential risk of harm (loss of sterile barrier protection). The source text explicitly states the calibration problems "have the potential to impact" sterility assurance, indicating a theoretical risk without reported illnesses or injuries, which fits the High (score 3) classification per the rubric.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits: DRAPE PACK (Model Number DYNJ35363A, Lot Number 21BBP020) and SICK KIDS-GENERAL CUSTOM SPLIT (Model Number SPTPCD10005, Lot Number 24JBB041). The recall affects 240 units distributed nationwide in the United States.
The company has identified calibration issues with the equipment used to sterilize and package these devices. Although all products underwent validated sterilization and packaging cycles, the identified calibration problems have the potential to impact the sterility assurance level of the recalled products.
Consumers or healthcare facilities in possession of these items should contact Medline Industries, LP for instructions on how to proceed. The FDA has classified this recall as Class II.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- loss-of-sterile-barrier
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 (8)
- 1) DYNJ35363A
- UDI-DI: 10884389516461(each)
- 40884389516462(case)
- Lot Number: 21BBP020
- 2) SPTPCD10005
- UDI-DI: 10080196228652(each)
- 40080196228653(case)
- Lot Number: 24JBB041
Distribution
Distributed nationwide across the United States.