Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk
Arrow International is recalling Pressure Injectable PICC Kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of needlestick injury, which aligns with the rubric criteria for 'Severe' severity (FDA Class II with injury reports).
Plain-English summary
Arrow International Inc. has initiated a recall of its Pressure Injectable PICC Kits. These medical devices are intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. The recall is being conducted due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle, which is packaged with certain Arrow products.
The affected products are identified by 510K # K061289 and material numbers EU-04041-HPMSB, EU-04052-HPMSB, EU-05041-HPMSB, and EU-05052-HPMSB. The firm reports that a total of 43,394 devices were distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using the affected PICC kits and contact Arrow International for further instructions on how to return or replace the devices. Users should be cautious of the potential for needlestick injuries if the safety cover on the packaged needle fails to remain engaged.
The recalled product
- Product
- Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — IV Catheters
- Affected units
- 43,394
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 (5)
- 510K # K061289
- Material numbers: EU-04041-HPMSB
- EU-04052-HPMSB
- EU-05041-HPMSB
- and EU-05052-HPMSB.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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