Arrow access tray MC3 contains drugs from a recalled supplier
The Arrow Access Tray, REF ASK-04001-MC3, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 8,265 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Arrow International is recalling the Access Tray, REF ASK-04001-MC3. The action covers 8,265 units.
Lidocaine, bupivacaine and 0.9% sodium chloride, the subject of a supplier recall, were included in the kits and sets. According to the manufacturer, the supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States across a large number of states. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF and the UDI-DI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Arrow International.
The recalled product
- Product
- Description/REF: ACCESS TRAY/ASK-04001-MC3
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 8,265
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 (1)
- REF(Material)/UDI-DI/Lot(Batch): ASK-04001-MC3/
Distribution
Part of a larger recall action
This product is one of 35 recalled by ARROW INTERNATIONAL, LLC 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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