# Arrow IPN032846 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Teleflex Incorporated](https://devicerts.com/manufacturers/teleflex-incorporated) (FDA registration: United States) - Name in the registry: ARROW IPN032846 - Device class: Class II (US FDA) - FDA product code: LJS - GMDN: Peripherally-inserted central venous catheter (36257) ## Registrations and authorizations - **GUDID** · GUDID listing · United States · UDI-DI 00801902094636 · listed 2015-10-16 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA 510(k) · United States · K112896 · decision 2012-05-10 · decision SESE · status: Active · from GUDID ## Recalls - Z-2378-2026 · Class I · ongoing · initiated 2026-04-21: 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. - Z-1822-2019 · Class II · terminated · initiated 2019-04-23: Lidstock states the incorrect expiration date for the product - Z-1820-2019 · Class II · terminated · initiated 2019-04-23: Lidstock states the incorrect expiration date for the product - Z-1811-2019 · Class II · terminated · initiated 2019-04-23: Lidstock states the incorrect expiration date for the product - Z-1819-2019 · Class II · terminated · initiated 2019-04-23: Lidstock states the incorrect expiration date for the product - Z-1327-2018 · Class II · terminated · initiated 2017-12-22 · matched through shared submission K112896, may concern other models: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. - Z-0996-2018 · Class II · terminated · initiated 2017-11-27: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. - Z-2698-2017 · Class II · terminated · initiated 2017-06-12: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. - Z-2331-2017 · Class II · terminated · initiated 2017-05-09: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. - Z-1705-2017 · Class II · terminated · initiated 2017-03-03: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844. - Z-0207-2016 · Class II · terminated · initiated 2015-10-16: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter. ## Identity - Trade name: ARROW [FDA GUDID (AccessGUDID)] - Generic name: Peripherally-inserted central venous catheter [FDA GUDID (AccessGUDID)] - Model / Ref / Catalog: IPN032846 [FDA GUDID (AccessGUDID)]; ASK-45041-BRZ [FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 00801902094636 [FDA GUDID (AccessGUDID)] - 510(k) Number: K112896 [FDA GUDID (AccessGUDID)] - FDA product code: LJS [FDA GUDID (AccessGUDID)] - GMDN term: Peripherally-inserted central venous catheter (36257) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class II [FDA GUDID (AccessGUDID)] - Regulation number: 880.5970 [FDA GUDID (AccessGUDID)] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Properties - Supplied sterile: Yes [FDA GUDID (AccessGUDID)] - Single use: Yes [FDA GUDID (AccessGUDID)] - Implantable: Yes [FDA GUDID (AccessGUDID)] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Convenience kit: Yes [FDA GUDID (AccessGUDID)] - Lot / batch number: Yes [FDA GUDID (AccessGUDID)] - Expiration date: Yes [FDA GUDID (AccessGUDID)] - Sterilise before use: No [FDA GUDID (AccessGUDID)] - Contains latex: No [FDA GUDID (AccessGUDID)] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - Combination product: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Serial number: No [FDA GUDID (AccessGUDID)] - Manufacturing date: No [FDA GUDID (AccessGUDID)] ## Source and citation - Cite as: Arrow IPN032846, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-ask-45041-brz (data as of 2026-11-14). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/arrow-ask-45041-brz - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.