Arrow IPN928657
Arrow IPN928657 (CDC-32052-MPKC) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K213855 on 2 Sep 2022 and listed in FDA GUDID since 13 Sep 2023 (UDI-DI 10801902216837), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10801902216837 | Date13 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213855 | Date2 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 10801902216837
- FDA 510(k) database K213855
Across registries
- FDA 510(k) K213855 decided 2 Sep 2022 Active
- FDA GUDID UDI-DI 10801902216837 listed 13 Sep 2023 Listed
Recalls
-
- Ongoing Z-2387-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Timeline
- Cleared FDA 510(k) K213855
- Listed FDA GUDID 10801902216837
- Recall initiated FDA recalls Z-2387-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arrow
- Generic name
- Peripheral intravenous catheterization kit, non-sensing
- Model / Ref / Catalog
- IPN928657, CDC-32052-MPKC
- Primary DI / UDI-DI
- 10801902216837
- 510(k) Number
- FDA product code
- PND
- GMDN term
- Peripheral intravenous catheterization kit, non-sensing
- Device class
- Class II
- Regulation number
- 880.5200
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices
Other devices filed under FDA product code PND (Midline catheter).
- Arrow Pressure Injectable Midline Catheter by Arrow International LLC (Subsidiary of Teleflex Incorporated)
- CT Midline by Medical Components, Inc. (dba MedComp)
- PowerMidline Catheter by C. R. Bard, Inc.
- ArchFlo CT Midline by Medcomp (Medical Components, Inc.)
- primeMidline Catheters by Pfm Medical, Inc.
- Provena(TM) Midline Catheter by C. R. Bard, Inc.
- Midline Catheter by Terumo Medical Products (Hangzhou) Co., Ltd.
- Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter by Vygon USA
- ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Stiletto Extended Dwell Catheter by Piper Access, LLC