Device recall: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

Class II FDA enforcement event 84688. Recall start date: 20 Dec 2019. Status in the FDA record: Terminated. Termination date: 25 Feb 2021.

Reason for recall, in the words of FDA

Product lidstock contains the incorrect expiration date for the product

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Arrow International Inc started this device recall on 20 Dec 2019. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 84688 has 20 product records. The first FDA enforcement report date is 26 Feb 2020. The record gives the status Terminated, with the termination date 25 Feb 2021.

FDA enforcement report The 20 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

Recalling firm

Arrow International Inc, Reading, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

20 product records in the event.

FDA event 84688: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1236-2020	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1	250 units	Class II	Terminated	26 Feb 2020
Z-1237-2020	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC		Class II	Terminated	26 Feb 2020
Z-1238-2020	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN	205	Class II	Terminated	26 Feb 2020
Z-1239-2020	Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH	1150 units	Class II	Terminated	26 Feb 2020
Z-1240-2020	Arrow Maximal Barrier Drape ASK-00002-1A	2080	Class II	Terminated	26 Feb 2020
Z-1241-2020	Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1	155	Class II	Terminated	26 Feb 2020
Z-1242-2020	Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM	410	Class II	Terminated	26 Feb 2020
Z-1243-2020	Arrow Central Venous Catheterization Kit ASK-04200-UPM	140	Class II	Terminated	26 Feb 2020
Z-1244-2020	Arrow EPIDURAL NEEDLE COMPONENT AN-05505	1839	Class II	Terminated	26 Feb 2020
Z-1245-2020	Arrow EPIDURAL CATHETERIZATION KIT AK-05000	870	Class II	Terminated	26 Feb 2020
Z-1246-2020	Arrow EPIDURAL CATHETERIZATION KIT YC-02220	160	Class II	Terminated	26 Feb 2020
Z-1247-2020	Arrow EPIDURAL CATHETERIZATION KIT JH-05500	1760	Class II	Terminated	26 Feb 2020
Z-1248-2020	Arrow EPIDURAL CATHETERIZATION KIT AM-05500	1320	Class II	Terminated	26 Feb 2020
Z-1249-2020	Arrow EPIDURAL CATHETERIZATION KIT CK-02220	1360	Class II	Terminated	26 Feb 2020
Z-1250-2020	Arrow SPINAL ANESTHESIA SET ASA-25090-S	90	Class II	Terminated	26 Feb 2020
Z-1251-2020	Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000	540	Class II	Terminated	26 Feb 2020
Z-1252-2020	Arrow EPIDURAL NEEDLE KIT SL-05500	180	Class II	Terminated	26 Feb 2020
Z-1253-2020	(1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6)…	2126	Class II	Terminated	26 Feb 2020
Z-1254-2020	PICC Set- PR-35052-HPHNM		Class II	Terminated	26 Feb 2020
Z-1255-2020	Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB		Class II	Terminated	26 Feb 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 20Median of the firm: 1
Events of the firm on the register: 93

Other events of the firm

Other FDA enforcement events of Arrow International Inc
Initiated	Product (first record)	Type	Class	Records
26 Jul 2024	Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Inc	Device	Class II	1
29 Apr 2024	Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS	Device	Class I	3
12 Feb 2024	ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FM	Device	Class I	1
10 Aug 2023	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R	Device	Class I	4
10 Aug 2023	Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular	Device	Class II	2
19 May 2023	ARROW Endurance Extended Dwell Peripheral Catheter System	Device	Class I	1
27 Oct 2022	Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer	Device	Class I	2
17 Oct 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump	Device	Class I	31
14 Sep 2022	ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH	Device	Class II	1
5 May 2022	Arrow Three-Lumen CVC	Device	Class II	1

Arrow International Inc: all 93 events

Official channels

FDA enforcement report Z-1236-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 84688. https://recallregister.com/fda/ii/84688/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
What quantity of product is in FDA event 84688?: The event has 20 product records. The first record gives this quantity: 250 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.