Arrow International Recalls Central Venous Access Kits Due to Sterility Concerns
Arrow International is recalling specific lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits because the catheters may not be completely sealed, compromising 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 aligns with 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 Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits and Arrowg+ard Blue PSI Kits. The recall involves specific product numbers including ASK-21142-RH, ASK-21242-MMC1, ASK-21242-UCD, CDC-21242-1A, CDC-29803-1A, and CDC-29903-1A.
The recall is being conducted because certain lots of cardiovascular catheters 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 providers and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lot numbers, it should be removed from use and returned to the manufacturer or distributor for replacement or refund.
The recalled product
- Product
- (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+a
- 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) 13F16L0254
- 13F17B0196
- 13F17C0046
- (2) 13F17D0212
- 13F17E0770
- 13F17F0438
- (3) 13F17E0656
- 13F17F0188
- 13F17F0459
- (4) 13F17B0139
- 13F17B0140
- 13F17B0141
- 13F17B0142
- 13F17D0131
- 13F17D0141
- 13F17E0509
- 13F17E0510
- 13F17E0867
- 13F17F0439
- (5) 13F17C0339
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
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19