Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues
Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.
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 3/5 (High).
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 due to packaging defects, creating a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling 5,507 units of HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip (Material HO-14703). The recall is due to a defect where the product packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
The affected products were distributed nationwide in the United States to the states of AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV. The products were also distributed to Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates, and the United Kingdom.
Healthcare providers and facilities should check their inventory for the specific lot codes listed in the recall notice. If the packaging is found to be unsealed or compromised, the product should not be used. Users should contact Arrow International Inc for further instructions on returning or disposing of the affected units.
The recalled product
- Product
- HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Affected units
- 5,507
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 (8)
- 14F15G0105
- 14F15H0230
- 14F15L0085
- 14F16A0438
- 14F16C0142
- 14F16D0060
- 14F16F0046
- 14F16F0564
Distribution
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.
See all 2 products in this recall →Related recalls
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