Surgical Convenience Kits Recalled Due to Compromised Sterility of External Wrapping
Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a theoretical risk-of-harm situation involving medical device sterility without reported illnesses or injuries. The Class II FDA classification indicates a potentially serious condition, but the absence of any reported harm limits the severity to the High category.
Plain-English summary
Medline Industries, LP is recalling 630 units of surgical convenience kits distributed nationwide. The recalled products include the Medline General Utility kit (Reorder Number DYNDA2524), Centurion Medical Products Dialysis On/Off Bundle (Reorder Number DT22705A), Centurion Medical Products Ultrasound PIV Bundle (Reorder Number IV8635D), and Centurion Medical Products Cutdown Tray (Reorder Number MNS12595).
The recall is due to a design flaw in the perforated bag that prevents the outside of the kit wrapping from remaining sterile. Only the contents inside the kit wrapping maintain sterile integrity. This compromised outer sterility could potentially allow contamination during storage or transport before the kit is used.
Affected lot numbers are: DYNDA2524 (Lot 22HME893), DT22705A (Lot 22HMC897), IV8635D (Lot 22HMH318), and MNS12595 (Lot 22HMD598). Healthcare facilities and providers who have received these kits should follow instructions provided by Medline Industries regarding the recall.
The recalled product
- Product
- Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 630
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 (9)
- a) Reorder Number DYNDA2524
- GTIN 40193489361415
- Lot # 22HME893 b) Reorder Number DT22705A
- GTIN 40653160993224
- Lot # 22HMC897 c) Reorder Number IV8635D
- GTIN 40653160990261
- Lot# 22HMH318 d) Reorder Number MNS12595
- GTIN 40653160991015
- Lot # 22HMD598
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
See all 20 products in this recall →Related recalls
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