Arrow Select Kits (ASK), Maximal Barrier Precautions Kits… recallZ-1030-2015 · Arrow International Inc · initiated Jan 9, 2015
Class III Terminated All recalls posted in January 2015
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
Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
FDA root cause category: Packaging process control
What the company is doing
Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.
Recall details
- Recall number
- Z-1030-2015
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Jan 9, 2015
- Posted by the FDA
- Jan 29, 2015
- Recalling firm
- Arrow International Inc
- Quantity
- 4484
- Product code
- OBJ
- FDA submissions
- K121941, K122545
- Distribution
- US (nationwide) and PR.
Product description
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Code information (models, lots, serial numbers)
Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120
Other devices under the same FDA submission
10 devices cleared under K121941, K122545 — 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 IPN924156Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall6 reports
- ARROW IPN056680Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- ARROW IPN919384Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN056332Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days7 reports
- ARROW IPN056359Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days4 reports
- ARROW IPN056682Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days3 reports
- ARROW IPN036755Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days2 reports
- ARROW IPN056333Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- ARROW IPN036730Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- ARROW IPN036749Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
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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