Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal
Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.
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: FDA Class II medical device with potential contamination due to compromised sterilization seals. No reported illnesses or injuries in the source. This meets the rubric criterion for score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling sterile surgical kits (REF DYNJ50099C) used in medical and surgical procedures. The recall involves 96 kits distributed in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
The company received complaints that breather pouches within some of the sterile surgical kits have openings in the seal. These openings compromise the sterility of the kit and could allow contamination of the contents.
Healthcare facilities that received this product should identify affected kits using lot number 22DBL482 and GTIN code 4019532701228. Affected kits should not be used. Customers should contact Medline Industries for instructions on returns or disposition of the recalled product.
The recalled product
- Product
- MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 96
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 (2)
- GTIN (01) 4019532701228
- Lot Number 22DBL482
Distribution
Part of a larger recall action
This product is one of 13 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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