Arrow Edge hemodialysis kits contain a sheath introducer that may not split
Arrow Edge Hemodialysis Catheterization Products are being recalled because they include a 16F splittable sheath introducer, subject to a supplier recall, that may not split as intended.
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 Edge Hemodialysis Catheterization Products, REF CS-15242-I, CS-15282-I and CS-15322-I, are being recalled. The action covers 285 units.
A 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in the impacted hemodialysis kits and sets. The sheath introducer may not split as intended, which may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury and vessel wall injury. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, covering the United States nationwide and a large number of other countries. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 285
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 (5)
- REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536
- CS-15282-I/30801902195532/33F23C0877
- 33F24A0281
- 33F24H0041
- CS-15322-I/30801902197451/33F23G0545
Distribution
Part of a larger recall action
This product is one of 4 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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