Arrow JACC Central Catheter Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 12 units of JACC central catheters because the expiration date printed on the packaging is incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Arrow International Inc. is recalling 12 units of Arrow JACC with Chloraguard Technology Jugular Axillosubclavian Central Catheters. The recall was initiated because the expiration date listed on the product is incorrect.
The affected product is identified by the batch code 23F18A0636. The recall covers units distributed nationwide and to foreign locations.
Healthcare facilities and consumers should stop using the affected catheters and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 12
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)
- Batch Code: 23F18A0636
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 36 recalled by Arrow International Inc 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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