Medline Convenience Kits recalled for potential sterilization issues
Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.
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 sterilization equipment calibration defects that could compromise sterility assurance levels of surgical and medical kits used in invasive procedures. Compromised sterility in surgical devices without reported illnesses but with risk of serious infection meets the Severe threshold per the rubric criterion for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling approximately 11,575 units of various Medline Convenience Kits distributed nationwide. The recall affects multiple product models including cochlear supplement kits, head and neck kits, bronchoscopy kits, and related ENT surgical kits.
The company identified calibration issues with the equipment used to sterilize and package these devices. Although all recalled products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the devices.
Healthcare facilities and medical professionals who have received these products should contact Medline Industries for instructions on how to proceed. Consumers or healthcare providers with questions can reference the specific lot numbers and UDI codes provided in the FDA's database for identification of affected units.
The recalled product
- Product
- See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5)…
- Manufacturer
- Medline Industries, LP
- Affected units
- 11,575
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) CDS983069G
- UDI-DI: 10193489923926(each)
- 40193489923927(case)
- Lot Number: 21HBO921
- 2) CDS983069G
- Lot Number: 21IBD399
- 3) CDS983069I
- UDI-DI: 10195327071868(each)
- 40195327071869(case)
- Lot Number: 22FBX804
- 4) CDS983069I
- Lot Number: 22GBE731
- 5) CDS983069I
- Lot Number: 22JBW315
- 6) CDS983782C
- UDI-DI: 10193489592047(each)
- 40193489592048(case)
- Lot Number: 21DKA756
- 7) DYKE1456D
- UDI-DI: 10195327639938(each)
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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