Medline Centurion surgical trays and kits recalled for potential non-sterile solutions
Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.
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 mandates a minimum severity score of 4 per the rubric rules. No illnesses or deaths have been reported; however, non-sterile surgical irrigation solutions present a significant potential risk.
Plain-English summary
Medline Industries, LP is recalling multiple Centurion surgical kits and trays manufactured with Nurse Assist irrigation solution components. The recall affects 14,234 units that include basic procedure trays, wound closure kits, circumcision trays, laceration trays, driveline management kits, and other sterile surgical packs.
The Nurse Assist component supplier issued a recall of its irrigation solutions—0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes—due to a potential lack of sterility, which could result in non-sterile solutions.
The affected Medline kits were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, the United Arab Emirates, and Panama. Healthcare facilities and providers should immediately quarantine any affected kits and contact Medline Industries for instructions on returns or replacements. Do not use the affected products.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 14,234
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) MNS13600
- 00653160349887 (case)
- 10653160349884 (unit)
- Lot Numbers: 2022022350
- 2022041880
- b) DM640A
- 00653160357271 (case)
- 10653160357278 (unit)
- Lot Numbers: 2022122090
- 2022122890
- 2023073190
- c) CIT6180
- 00653160290691 (case)
- 10653160290698 (unit)
- Lot Numbers: 2023080290
- d) ID1690
- 10653160235903 (case)
- 00653160235906 (unit)
- Lot Numbers: 2022071390
- 2022120790
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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