Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile surgical convenience kits due to potential open or weak seals on the breather pouches used for packaging. The compromised seals could affect product 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: This is an FDA Class II recall of sterile medical devices where compromised packaging could result in loss of sterility and potential patient harm. Although no illnesses or injuries have been reported, the risk to patient safety from non-sterile surgical instruments is significant.
Plain-English summary
Medline Industries, LP is recalling eight models of sterile surgical convenience kits used for gynecologic and hysteroscopic procedures. The kits affected include Peri Gyn Pack, D & C Hysteroscopy Pack, Vaginal Hysterectomy WRH-LF, Hyster/Resectoscope, and Hysteroscopy Pack models, distributed worldwide including the United States, Canada, Mexico, Panama, and the Virgin Islands.
The recall is due to a potential for open or weak seals on the breather pouches used to package these sterile kits. Compromised seals could allow the sterile contents to become contaminated during storage or transport.
A total of 671 units have been distributed. Healthcare providers and hospitals currently using or possessing these kits should stop using them and contact Medline Industries for instructions on replacement or return. Specific lot numbers and UDI identifiers for each affected kit model have been identified and are available through the FDA.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 671
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) DYNJ80786
- UDI-DI: 10195327079451(each)
- 40195327079452(case)
- Lot Number: 24IBH305
- 2) DYNJ21937J
- UDI-DI: 10195327694876(each)
- 40195327694877(case)
- Lot Number: 24JBN378
- 3) DYNJ41949B
- UDI-DI: 10195327128937(each)
- 40195327128938(case)
- Lot Number: 24JBT902
- 4) DYNJ21824R
- UDI-DI: 10195327107758(each)
- 40195327107759(case)
- Lot Number: 24JBU465
- 5) DYNJ67708A
- UDI-DI: 10195327039899(each)
- 40195327039890(case)
- Lot Number: 24JBV636
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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