Arrow PICC Catheters Recalled Due to Potential Sterility Compromise
Arrow International Inc. is recalling 416,055 PICC catheters because unsealed packaging may have compromised product 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which poses a risk of infection, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of Arrow PICC with Chloraguard Technology. The recall is due to a defect where product sterility may be compromised due to unsealed packaging.
The affected products include various product codes such as PR-44041-BAS, PR-44052-BAS, and PR-45563-HPHNM, among others. Specific lot numbers are listed in the agency's recall record. The products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
Healthcare providers and consumers should stop using these specific products and contact Arrow International Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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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