Medline Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 3,752 Labor CDS and Vag Delivery Admission Bags due to packaging wrinkles that may compromise sterility, risking microbial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the source text describes a risk of serious infection and hospitalization without reporting specific confirmed injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 3,752 units of two specific medical device kits: the Labor CDS (Model CDS981762B) and the Vag Delivery Admission Bag (Model DYKA1054F). These kits were distributed nationwide in the United States. The recall involves specific lots of these products, which contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators.
The recall was initiated because of a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection. In less common cases, more serious infections may require medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and stop using the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 3,752
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 (20)
- 1) CDS981762B
- UDI-DI: 10193489306767(each)
- 40193489306768(case)
- Lot Number: 25ABK513
- 2) CDS981762B
- Lot Number: 25DBM841
- 3) CDS981762B
- Lot Number: 25EBU475
- 4) CDS981762B
- Lot Number: 25FBQ817
- 5) CDS981762B
- Lot Number: 25HBK086
- 6) CDS981762B
- Lot Number: 23LBV280
- 7) CDS981762B
- Lot Number: 24BBN930
- 8) CDS981762B
- Lot Number: 24DBK663
- 9) CDS981762B
- Lot Number: 24DBS890
Distribution
Distributed nationwide across the United States.
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