Sterile radiology procedure kits may have a breached sterile pouch
One lot of Sterile Radiology Procedure Kits, model DYNDH1491B, is being recalled because of a potential breach in the sterile pouch packaging that may compromise sterility.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a breached sterile barrier may leave the kit non-sterile at the point of use, and no injuries are stated in the source.
Plain-English summary
Sterile Radiology Procedure Kits, model number DYNDH1491B, are being recalled. About 420 units were distributed in Minnesota. The FDA has classified this recall as Class II.
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Affected product is identified by the model number above.
Facilities can identify affected kits by the model number, and may contact the recalling firm for further information.
The recalled product
- Product
- Sterile Radiology Procedure Kits, Model Number DYNDH1491B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 420
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)
- UDI-DI: (CS) 40198459071455
- (EA) 10198459071454
- Lot Number: 25GBB924
Distribution
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