Medline Birthing Room Pack surgical kits recalled due to weak sterile seals
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
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: Risk-of-harm medical device (sterile surgical kit) where compromised sterility could cause serious infection; no illnesses, injuries, or hospitalizations reported in source text.
Plain-English summary
Medline Industries is recalling Birthing Room Pack sterile convenience kits due to weak seals on Pure Pouch components. The affected kits were distributed nationwide to healthcare facilities in 23 states.
The weak seals may fail and breach the sterility of the surgical instruments and supplies contained in the kits. This could compromise the intended sterile environment for childbirth procedures.
Approximately 12,588 kits with Pack #DYNJ38429D are affected by this recall. Healthcare facilities that received these kits should check the product lot numbers to determine if they are affected. Do not use kits if seals appear weak, damaged, or compromised.
The recalled product
- Product
- Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 12,588
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 (7)
- Pack #DYNJ38429D containing component 65945 - lot numbers 23JMF534
- exp. 12/31/2024
- 23JMC032
- exp. 5/31/2024
- 23HMD025
- and 23GMC207
- exp. 5/31/2024.
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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