Medline Sterile Obstetrical Procedure Kits Recalled for Potential Packaging Seal Defects
Medline is recalling 21,935 sterile convenience kits used for obstetrical procedures due to potential open or weak seals on breather pouches that could compromise product sterility. The kits were distributed nationwide and internationally.
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 recall with no reported illnesses or injuries. The hazard—potential open or weak seals on sterile device packaging—is theoretical in terms of actual harm, placing this at the maximum score of 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling approximately 21,935 sterile convenience kits used for obstetrical procedures, including labor and delivery packs and vaginal delivery kits. The kits are used by healthcare facilities for various obstetrical procedures.
The recall was issued due to a potential issue with open or weak seals on breather pouches used in the packaging of these kits. A compromised seal could allow the product to lose its sterile status.
The affected kits were manufactured with lot numbers ranging from 24IBD872 through 25ABA840 and distributed worldwide, including the United States, Canada, Mexico, Panama, and the Virgin Islands.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seals
- sterility-compromise
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) DYNJ26971L
- UDI-DI: 10198459087158(each)
- 40198459087159(case)
- Lot Number: 24IBD872
- 2) DYNJ0378319P
- UDI-DI: 10198459105722(each)
- 40198459105723(case)
- Lot Number: 24IBF374
- 3) DYNJ64017B
- UDI-DI: 10195327550325(each)
- 40195327550326(case)
- Lot Number: 24IBG070
- 4) DYNJHTLD04A
- UDI-DI: 10193489303346(each)
- 40193489303347(case)
- Lot Number: 24IBH288
- 5) HM190A
- UDI-DI: 10195327305161(each)
- 40195327305162(case)
- Lot Number: 24IBH818
Distribution
Distributed nationwide across the United States.
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