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.
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 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
- Affected units
- 139
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
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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