Arrow PICC Two Lumen Peripherally Inserted Central Catheter… recallZ-0552-05 · Arrow International Inc · initiated Sep 21, 2004
Terminated All recalls posted in February 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was mislabeled for lumen configuration, flow rates, and priming volume.
FDA root cause category: Other
What the company is doing
The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.
Recall details
- Recall number
- Z-0552-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 21, 2004
- Posted by the FDA
- Feb 18, 2005
- Recalling firm
- Arrow International Inc
- Quantity
- 25 kits
- Product code
- LJS
- FDA submissions
- K930129
- Distribution
- The products were shipped to hospitals in AZ, CA, NJ, and WV.
Product description
Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
Code information (models, lots, serial numbers)
Lot numbers RF4088611 and RF4088128
Other devices under the same FDA submission
1 device cleared under K930129 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN036421Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 30089).
- Z-0551-05 · TerminatedArrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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