Medline Convenience Kits recalled for potential sterilization issue
Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.
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: This is an FDA Class II recall for sterile medical devices (PICC lines, central line trays, and related kits). The source text does not report any illnesses or injuries, but the potential compromise of sterility assurance in devices used for invasive procedures presents a risk of harm. Per the rubric, Class II recalls with risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Medline Industries, LP is recalling multiple models of medical convenience kits including PICC line trays, code cart central line kits, vein procedure kits, and NICU central line trays. These kits are used in healthcare settings for peripheral insertion, central venous access, and other medical procedures.
The recall was initiated after Medline identified calibration issues with the equipment used to sterilize and package these devices. Although 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 affected products. A total of 5,562 units have been distributed nationwide in the United States.
Medline has classified this as a Class II recall. Healthcare facilities and practitioners who have received these kits should contact Medline to determine which lot numbers they have in stock and receive instructions on handling or return of affected products. Patients or caregivers should not attempt to use or discard recalled kits without healthcare provider guidance.
The recalled product
- Product
- Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY…
- Manufacturer
- Medline Industries, LP
- Affected units
- 5,562
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) 00-401993O
- UDI-DI: 10195327517366(each)
- 40195327517367(case)
- Lot Number: 23KBH528
- 2) ACC010268B
- UDI-DI: 10889942197477(each)
- 40889942197478(case)
- Lot Number: 21BDB379
- 3) ACC010268B
- Lot Number: 21CDB078
- 4) ACC010268B
- Lot Number: 21IDC222
- 5) ACC010268B
- Lot Number: 21JDB458
- 6) ACC010268B
- Lot Number: 22ADC105
- 7) ACC010268B
- Lot Number: 22BDA862
- 8) ACC010268B
- Lot Number: 22CDC433
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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