Arrow International Recalls Certain Lots of Central Venous Catheter Kits
Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be guaranteed, posing a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling certain lots of AGB+ and ARROWg+ard central venous catheterization (CVC) kits. The recall covers various multi-lumen, pressure injectable, and quad-lumen kits, including specific part numbers and lot numbers listed in the agency's official notice.
The recall was initiated because the cardiovascular catheters in these kits may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. The affected products were distributed in all 50 U.S. states, the District of Columbia, and in the Bahamas, Canada, Mexico, Panama, and Singapore.
Healthcare facilities and consumers should check their inventory for the specific part numbers and lot numbers identified in the recall. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-4585
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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 (20)
- Lot Numbers: (1) 13F17A0135
- 13F17C0355
- 13F17E0212
- 13F17E0789
- 13F17F0386
- (2) 13F17A0028
- 13F17E0044
- 13F17E0448
- (3) 13F17B0118
- 13F17F0385
- (4) 13F17B0152
- 13F17C0057
- (5) 13F17F0226
- (6) 13F17A0157
- 13F17B0117
- 13F17C0250
- (7) 13F17F0071
- (8) 13F17A0022
- 13F17A0301
- 13F17C0266
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 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.
See all 14 products in this recall →Related recalls
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