Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
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 involves a potential loss of sterility in medical devices, which represents a high-risk hazard where injury has not yet been reported.
Plain-English summary
Medline Industries, LP has identified issues related to the calibration of equipment used to sterilize and package several Medline Convenience Kits. While all products were exposed to validated sterilization and packaging cycles, the calibration issues create a potential impact on the sterility assurance level (SAL) of the recalled products.
The affected products include various Medline Convenience Kits, such as Hysteroscopy, GYN Oncology Lap, and Vaginal Hysterectomy packs, across multiple model numbers. This recall is being conducted on a worldwide basis, including throughout the United States.
Consumers and healthcare providers should check their inventory for the specific model numbers and lot numbers listed in the official notice to determine if they possess affected units.
The recalled product
- Product
- Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 4,415
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) CDS984086I
- UDI-DI: 10195327428006(each)
- 40195327428007(case)
- Lot Number: 24CBQ563
- 2) CDS984086I
- Lot Number: 24ABO363
- 3) CDS984086I
- Lot Number: 23IBV204
- 4) CDS984086I
- Lot Number: 23HBY878
- 5) CDS984086I
- Lot Number: 23GBE705
- 6) DYKMBNDL91A
- UDI-DI: 10195327246891(each)
- 40195327246892(case)
- Lot Number: 23HBI773
- 7) DYKMBNDL91A
- Lot Number: 23FBD256
- 8) DYKMBNDL91A
- Lot Number: 23FBC116
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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