Peritoneal Lavage Kits, Model number AK-09000 recallZ-1408-04 · Arrow International Inc · initiated Aug 2, 2004
Terminated All recalls posted in August 2004
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
wrong introducer needle in some kits
FDA root cause category: Other
What the company is doing
The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
Recall details
- Recall number
- Z-1408-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 2, 2004
- Posted by the FDA
- Aug 25, 2004
- Recalling firm
- Arrow International Inc
- Quantity
- 9100 units
- Product code
- GBW
- FDA submissions
- K811627
- Distribution
- The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
Product description
Peritoneal Lavage Kits, Model number AK-09000
Code information (models, lots, serial numbers)
Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06.
Other devices under the same FDA submission
2 devices cleared under K811627 — 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 IPN036986Teleflex Incorporated · CATHETER, PERITONEAL2 recalls0 reports
- ARROW IPN032635Teleflex Incorporated · CATHETER, PERITONEAL2 reports
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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