Medline eye trays contain insulin syringes labeled as tuberculin syringes
Medline EYE TRAY-LF kits are being recalled because they contain Cardinal Health syringes packaged as 1 mL tuberculin syringes but which are actually U-100 insulin syringes.
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: FDA Class II recall where a syringe with a different graduation scale is supplied under the wrong label, creating a dosing risk of harm with no injuries reported.
Plain-English summary
The Medline medical convenience kit labeled EYE TRAY-LF, Medline kit SKU DYNJ21627P, lot 26BMC538, is being recalled. The action covers eight kits.
The affected kits contain Cardinal Health Monoject 1 mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (product code 1180100777), but the syringes inside are U-100 insulin syringes. The two syringe types carry different graduation scales. The FDA classified the action as Class II.
Distribution was within the United States, in California. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the Medline SKU, UDI and lot number above, quarantine them, and follow the instructions issued by Medline.
The recalled product
- Product
- Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 8
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 10198459151569 (each)
- 40198459151560 (case)
- Lot Numbers: 26BMC538
Distribution
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