Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified as FDA Class I, which per the severity rubric constitutes a critical-level recall. Non-sterile surgical irrigation solutions pose a serious infection risk in medical device applications.
Plain-English summary
Medline Industries, LP is recalling 533 units of specific gynecological laparoscopy kits and surgical trays manufactured with certain lots of Nurse Assist components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe.
The recall was initiated because the irrigation and saline solutions used in these kits may not be sterile as required for medical device use. Non-sterile solutions pose a serious risk of infection when used in surgical procedures.
The affected kits were distributed US nationwide, including Puerto Rico, as well as internationally to Canada, the United Arab Emirates, and Panama. Specific product reference numbers and lot numbers are identified in the FDA notice. Healthcare facilities and organizations using these products should verify their inventory against the affected lot numbers and discontinue use of any identified units.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 533
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)
- a) REF CDS984900M
- UDI/DI 40195327265671 (case)
- 10195327265670 (unit)
- Lot Numbers: 22KBW682
- b) REF CDS983913S
- UDI/DI 40195327057139 (case)
- 10195327057138 (unit)
- Lot Numbers: 22EBH289
- 22EBI056
- 22GBC582
- 22GBH056
- 22JBN751
- 22NBC011
- c) REF CDS983913T
- UDI/DI 40195327238378 (case)
- 10195327238377 (unit)
- Lot Numbers: 22KBK694
- 23BBA876
- 23BBA877
- 23BBN921
Distribution
Part of a larger recall action
This product is one of 49 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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