Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in invasive surgical and obstetrical procedures where loss of sterility assurance creates significant risk of serious injury or infection. The potential compromise of sterility in labor, delivery, and gynecological surgical kits represents a substantial hazard to patient safety.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits for labor, delivery, and gynecological procedures. The recall affects 57 different kit models with numerous lot numbers distributed nationwide and worldwide. The products include OB kits, labor and delivery packs, vaginal delivery packs, and related surgical kits.
Medline identified calibration issues with equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities and providers who have received these kits should stop using them and contact Medline Industries for instructions on return or replacement. Patients who may have been exposed to non-sterile devices during procedures should consult their healthcare provider.
The recalled product
- Product
- Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY…
- Manufacturer
- Medline Industries, LP
- Affected units
- 29,192
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) DYKM2326
- UDI-DI: 10198459565748(each)
- 40198459565749(case)
- Lot Number: 25KMF765
- 2) DYKMBNDL165
- UDI-DI: 10193489477405(each)
- 40193489477406(case)
- Lot Number: 21ABI982
- 3) DYKMBNDL165
- Lot Number: 21ABT654
- 4) DYKMBNDL165
- Lot Number: 21DBA335
- 5) DYKMBNDL165
- Lot Number: 21EBE875
- 6) DYKMBNDL165
- Lot Number: 21FBP760
- 7) DYKMBNDL165
- Lot Number: 21GBN267
- 8) DYKMBNDL165
- Lot Number: 21IBE978
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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