Omnicell i.v.Station label stock rolls for syringe preparation
Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall, which per the rubric requires a minimum severity score of 4. Although no reported illnesses or injuries are stated in the source, the classification itself mandates the Severe rating, as Class I recalls involve products with a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Omnicell, Inc. is recalling specific rolls of label stock used with the Omnicell i.v.Station device. The affected items are Part Number 258920028 (LABEL, STERILE, IVSTATION SYRINGE 40MMx40MM, Lot Number QN 200023473) and Part Number 258900029 (LABEL, STERILE, IVSTATION SYRINGE 20MMx40MM, Lot Number QN 200023474). The i.v.Station is an automation device used for preparation and compounding of intravenous medications that also applies labels to compounded preparations for identification and traceability.
The reason for the recall is the potential for mislabeled syringes produced by the i.v.Station device. This could affect proper identification and traceability of IV medications.
The affected label stock was distributed in Alabama, Maryland, and Pennsylvania. A total of 220 units are involved in this recall. Customers who have received the affected label stock should contact Omnicell, Inc. for further instructions regarding replacement or corrective actions.
The recalled product
- Product
- Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automat
- Manufacturer
- Omnicell, Inc.
- Hazard
- mislabeling
- medication-identification-failure
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)
- 1. Part Number 258920028
- Lot Number: QN 200023473. 2. Part Number 258900029
- Lot Number: QN 200023474.
Distribution
Distribution scope not specified by the agency.