Medline Labor Pack medical device kits regulatory clearance rescinded
Medline Industries is recalling certain Labor Pack kits (Model DYNJ44813D) nationwide because their 510(k) regulatory clearances for Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
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 of medical devices used in labor/clinical settings. Loss of regulatory clearance for critical device components (syringes, guidewires, tubing) that directly contact patients represents a serious regulatory and safety deficiency, meeting the criteria for Severe classification.
Plain-English summary
Medline Industries, LP is recalling Medline Labor Pack kits (Model Number DYNJ44813D) distributed nationwide. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in these kits have been rescinded by the FDA.
Approximately 1,720 units are affected. The recall involves 20 specific lot numbers: 21CBJ477, 21GBE184, 21GBJ527, 21HBL388, 21IBT013, 21LBS718, 22BBD935, 22CBA262, 22FBM910, 22LBQ838, 22HBG782, 23FBS838, 23IBD099, 23KBA057, 24ABJ743, 24EBG776, 24FBC225, 24IBW215, 24LBU055, and 25DBP554.
Healthcare facilities and users should stop using affected kits and contact Medline Industries for replacement or guidance. Consult the FDA website or your healthcare provider if you have questions about this recall.
The recalled product
- Product
- Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Labor/OB Kit
- Affected units
- 1,720
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) DYNJ44813D
- UDI-DI: 10193489467642(each)
- 40193489467643(case)
- Lot Number: 21CBJ477
- 2) DYNJ44813D
- Lot Number: 21GBE184
- 3) DYNJ44813D
- Lot Number: 21GBJ527
- 4) DYNJ44813D
- Lot Number: 21HBL388
- 5) DYNJ44813D
- Lot Number: 21IBT013
- 6) DYNJ44813D
- Lot Number: 21LBS718
- 7) DYNJ44813D
- Lot Number: 22BBD935
- 8) DYNJ44813D
- Lot Number: 22CBA262
- 9) DYNJ44813D
- Lot Number: 22FBM910
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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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