Medline Sterile Maximum Barrier Pack-LF units recalled for sterilization failure
Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.
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 of surgical barrier packs where components failed to undergo sterilization due to improper placement. While no reported illnesses are noted in the source, the sterilization failure creates infection risk in a critical sterile medical device, warranting a High severity classification.
Plain-English summary
Medline Industries, LP is recalling Sterile Maximum Barrier Pack-LF convenience trays because some components were improperly placed in the nonsterile portion of the trays during manufacturing. As a result, these components did not receive proper sterilization. Approximately 720 trays were distributed to facilities in Arkansas, Colorado, and Georgia.
The recalled packs include Item DYNJ0248546C and DYNJ0248546D, which contain BD Chloraprep Hi-Lite Orange 10.5 mL applicators. Healthcare facilities that have received these products should identify and quarantine affected trays immediately. Affected lot numbers and expiration dates are provided in the FDA recall notice.
Consumers and healthcare providers who have questions about this recall should contact Medline Industries or visit the FDA's website for additional information.
The recalled product
- Product
- (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 720
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) UDI/DI (01) 40889942055518
- Lot numbers 21KBE911
- exp. 3/31/2023
- 21JBU806
- 21IBW034
- 21HBM415
- 21GBH194
- 21CBY712
- 21BBS824
- 21BBS043
- 20XBC895
- exp. 12/31/2022
- 20WBB357
- exp. 8/31/2022
- 20KBD323
- exp. 9/30/2022
- and 20JBT517
- exp. 12/31/2021. (2) UDI/DI (01) 40195327069286
- Lot number 22CBJ633
- exp. 12/31/2022.
Distribution
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
See all 3 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- SevereMedline Medical Device Kits Recalled for Potential Sterility Loss
FDA (Devices) · 2024-03-06
- SevereMedline Medical Kits and Trays Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- SevereMedline Prep Kits Recalled Due to Non-Sterile Components
FDA (Devices) · 2024-03-06
- SevereMedline Surgical Kits and Trays Recalled Due to Potential Sterility Defect
FDA (Devices) · 2024-03-06
- SevereMedline Irrigation Kits and Packs Recalled for Sterility Defect
FDA (Devices) · 2024-03-06
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06