Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility
Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.
What this means for you
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 risk-of-harm product involving potential infection from compromised sterile packaging integrity. No illness, injury, or adverse events are reported in the source material. Per the severity rubric, risk-of-harm products without reported injury correspond to Score 3 (High).
Plain-English summary
Medline Industries, LP is recalling 192 units of the CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY (Reorder Number SUT10675, Lot # 22HMG259) distributed nationwide.
The recall was initiated because the outer bag is perforated, preventing the outer wrapping from maintaining sterility. The contents inside the kit wrapping remain sterile, but the compromised outer bag may allow contamination that could affect the sterile field during interventional radiology procedures.
This recall affects healthcare facilities and surgical centers that received these units.
Healthcare providers who have received affected units should stop use and contact Medline Industries for replacement units or further instructions.
The recalled product
- Product
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 192
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 (3)
- Reorder Number SUT10675
- GTIN 40653160062845
- Lot # 22HMG259
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.
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