Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits
Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, 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, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc. is recalling certain lots of AGB+ Multi Lumen, Quad-Lumen, and Two-Lumen Central Venous Catheter (CVC) Kits. The recall includes specific part numbers and lot numbers identified in the agency's structured data. The products were distributed in all 50 U.S. states, the District of Columbia, and in the Bahamas, Canada, Mexico, Panama, and Singapore.
The recall is being conducted because certain lots of the cardiovascular catheters may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory against the specific part numbers and lot numbers listed in the official recall notice to identify affected units.
The recalled product
- Product
- AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A,
- 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) 13F17F0049
- (2) 13F17B0224
- 13F17E0142
- 13F17E0830
- (3) 13F16L0220
- (4) 13F17E0463
- 13F17F0169
- (5) 13F17E0685
- (6) 13F17D0275
- 13F17D0325
- (7) 13F17C0470
- 13F17D0243
- (8) 13F17E0358
- (9) 13F17B0031
- 13F17E0626
- (10) 13F17B0035
- 13F17E0627
- (11) 13F17B0135
- 13F17D0191
- (12) 13F16M0173
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.
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