Medline kits and trays recalled for potential lack of sterility
Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Under the severity rubric, FDA Class I recalls are scored at minimum 4 (Severe). No illnesses or injuries have been reported, but the potential for infection from non-sterile irrigation solutions used in surgical procedures justifies the FDA's Class I classification.
Plain-English summary
Medline Industries, LP is recalling certain kits, trays, and packs used in obstetrical and surgical procedures. The affected products include labor and delivery kits, laceration trays, obstetrical surgical kits, and vaginal delivery kits with specific reference numbers and lot identifications.
The recalled products contain irrigation solutions that were manufactured using components from Nurse Assist, specifically 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Nurse Assist identified a potential lack of sterility in these components, creating a risk that the irrigation solutions supplied in these kits may not be sterile.
The recalled products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama.
Healthcare facilities and individuals who have received these products should immediately discontinue use and contact Medline Industries or the FDA for guidance on proper handling, disposal, and replacement of affected units.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 2,903
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 CDS980273D
- UDI/DI 40884389851808 (case)
- 10884389851807 (unit)
- Lot Numbers: 22DBJ834
- b) REF DYNJ907794
- UDI/DI 40193489884952 (case)
- 10193489884951 (unit)
- Lot Numbers: 22BBB085
- 22CBW699
- 22FBH326
- 22KBJ007
- 22KBW578
- 23ABL612
- 23CBT573
- 23HBD177
- c) REF DYNDL1864A
- UDI/DI 40889942721420 (case)
- 10889942721429 (unit)
- Lot Numbers: 22FBN858
- 22IBN393
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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