Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility
Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.
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 Class II recall involves potential sterility compromise in surgical kits, representing a risk-of-harm product. No illnesses or injuries have been reported to date, and the hazard is contingent on seal failure, making it a theoretical rather than confirmed risk.
Plain-English summary
Medline Industries, LP is recalling nonsterile surgical convenience kits because the Pure Pouch component has weak seals that may compromise sterility if the seal fails. The affected kits include Medline Delivery and Medline C-Section packs, distributed to surgical facilities nationwide.
The weak seals present a risk that the sterile contents could be exposed to contamination if the seal is breached during handling or storage. This could result in infection or other adverse effects if the compromised instruments are used in surgical procedures.
The recall affects 7,673 kits distributed across 23 states. Specific lot numbers and expiration dates ranging from July to August 2024 are associated with the recall.
Healthcare facilities and surgical centers in possession of these kits should immediately discontinue use and contact Medline Industries for replacement products or further guidance.
The recalled product
- Product
- Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R.…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 7,673
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 (11)
- a. Pack #DYNJ901130I - Lot numbers 23GMH075
- exp. 7/31/2024
- and 23GMD605
- 23IMG375
- 23HMB336
- 23GMF342
- 23EMJ935
- and 23EMK254
- all exp. date 8/31/2024
- UDI-DI each-10193489946116
- UDI-DI case 40193489946117.
Distribution
Part of a larger recall action
This product is one of 9 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.
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