Arrow International Recalls Central Venous Access Kits Due to Incorrect Banner Card
Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.
What this means for you
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/packaging issue (incorrect banner card) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Arrow International Inc is recalling 520 units of the 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard, intended for use with 7.5 - 8 Fr. catheters. The specific product code is CDC-29803-1A, and the affected lot number is 13F18H0610. This device is a two-lumen central venous access device used to permit venous access and catheter introduction to the central circulation via the jugular, subclavian, or femoral veins.
The recall was initiated because the products may contain the incorrect banner card within the kit. The source text does not specify any reported injuries, illnesses, or other adverse health consequences associated with this labeling error. The affected units were distributed nationwide in the United States.
Healthcare providers and consumers should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It m
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 520
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)
- Lot Number: 13F18H0610
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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