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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95228

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 26, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ARROW INTERNATIONAL Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

Z-3299-2024
Recall number
Z-3299-2024
Initiated
July 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
14,845 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports have been received regarding open seals on the packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports have been received regarding open seals on the packaging.

Code information

(1) REF ASK-04001-BW1: Batch numbers 33F23M0157, 33F24C0002, 33F24C0136, and 33F23L0297, UDI-DI: 10801902117585; (2) REF ASK-04001-CK: Batch numbers 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, and 33F23L0738, UDI-DI: 00801902091215; (3) REF ASK-04001-VAMC1: Batch numbers 33F24A0825 and 33F24B0235, UDI-DI: 10801902158854; (4) REF ASK-04020-BHS: Batch numbers 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, and 33F23L0687, UDI-DI: 30801902144578; (5) REF ASK-04020-BID: Batch number 33F23J0777, UDI (1)10801902211429(17)260331(10)33F23J0777; (6) REF ASK-04020-HMC: Batch numbers 33F24A0743, 33F23L0747, and 33F24A1129, UDI-DI: 10801902117691; (7) REF ASK-04020-HOA: Batch number 33F24D0969, UDI: (1)10801902214802(17)251124(10)33F24D0969; (8) REF ASK-04020-KSD: Batch number 33F24D0964, UDI: (1)10801902219630(17)251130(10)33F24D0964; (9) REF ASK-04020-LOL: Batch numbers 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, and 33F23M0033, UDI-DI 10801902144765; (10) REF ASK-04020-MHS: Batch numbers 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, and 33F23L0734, UDI-DI 20801902117711(17)260426; (11) REF ASK-04020-MIB3: Batch number 33F24A0901, UDI (1)10801902206401(17)250831(10)33F24A0901; (12) REF ASK-04020-PRH: Batch number 33F23K0602, UDI (1)10801902155938(17)250731(10)33F23K0602; (13) REF ASK-04020-UOIL: Batch number 33F24B0001, UDI (1)10801902218978(17)261031(10)33F24B0001; (14) REF ASK-04220-KSP: Batch number 33F23L0323, UDI (1)10801902156409(17)250531(10)33F23L0323; and (15) REF ASK-04500-HFH4: Batch numbers 33F24C0436, 33F24A0617, and 33F23K1006, UDI-DI 10801902200461.

Distribution pattern

US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.