The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1794-2019·Announced 2019-06-26

Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling

Arrow International Inc is recalling 185 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates on the packaging.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate score.

Plain-English summary

Arrow International Inc is recalling 185 units of Arrow PICC with Chloraguard Technology (Product Code: CDA 45052 HPK1A) because the product was labeled with an incorrect expiration date. The affected units are identified by batch codes 23F17D0458 and 23F17H0763.

The recall was initiated by Lidstock, which identified the labeling error. The products were distributed nationwide and to foreign markets. No specific illnesses or injuries are reported in the source text.

Healthcare providers and consumers should stop using the affected units and contact Arrow International Inc for further instructions or a return.

The recalled product

Product
Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A
Affected units
185

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 (2)

  • Batch Code:23F17D0458
  • 23F17H0763

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 36 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 36 products in this recall →

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