Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries is recalling 139 surgical kits containing irrigation solutions with potential sterility issues. The recalled products were distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric guidelines. Although no reported illnesses or injuries exist, potential sterility issues in surgical irrigation components pose significant infection risk during surgical use.
Plain-English summary
Medline Industries, LP is recalling certain surgical kits and trays: a Breast Pack (REF DYNJ56344B) and a Septoplasty Pack WRO-LF (REF DYNJ62803). The kits contain irrigation solutions from Nurse Assist, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes. A total of 139 units are affected by this recall.
The recall was issued due to the potential lack of sterility in the irrigation solution components. Non-sterile solutions could compromise patient safety if used in surgical procedures.
The affected products were distributed throughout the United States, including Puerto Rico, and internationally to Canada, the United Arab Emirates, and Panama. Identification of affected products can be made using the following lot numbers: Breast Pack lots 22CLA043, 22HLA191, 22ILA180, 23BLA030, 23BLB019, 23ELA630; Septoplasty Pack lots 22GBS133, 23GBF930.
Individuals and healthcare facilities should identify affected products using the provided lot numbers and REF codes, then contact Medline Industries regarding the recall for further instructions.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- sterility-contamination
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 (14)
- a) REF DYNJ56344B
- UDI/DI 40889942612322 (case)
- 10889942612321 (unit)
- Lot Numbers: 22CLA043
- 22HLA191
- 22ILA180
- 23BLA030
- 23BLB019
- 23ELA630
- b) REF DYNJ62803
- UDI/DI 40193489688994 (case)
- 10193489688993 (unit)
- Lot Numbers: 22GBS133
- 23GBF930
Distribution
Distributed nationwide across the United States.
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