Home / Recalls / Arrow International Inc / Z-2023-2018

Z-2023-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

FDA device recall Z-2023-2018 was initiated by Arrow International Inc on Apr 11, 2018 and is designated Class II. Reason for recall: Product sterility may be compromised due to unsealed packaging. The recall status is terminated (terminated May 15, 2020). Affected quantity: 416,055 total products.

Recall Details

Product Type
Devices
Report Date
Jun 6, 2018
Initiation Date
Apr 11, 2018
Termination Date
May 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
416,055 total products

Product Description

ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM

Reason for Recall

Product sterility may be compromised due to unsealed packaging.

Distribution Pattern

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

Code Information

Lot Numbers: Product Code PR-34052-HPHNM: 13F17C0351 Product Code PR-34063-HPHNM: 13F17F0192 Product Code PR-35041-HPHNM: 13F17B0290 13F17C0231 13F17D0238 13F17F0276 13F17F0577 13F17H0365 13F17J0409 13F17K0490 13F17L0394 13F17L0395 Product Code PR-35052-HPHNM: 13F17B0092 13F17B0256 13F17C0043 13F17D0094 13F17D0239 13F17E0224 13F17F0586 13F17H0354 13F17J0196 13F17K0549 13F17L0474 13F17L0697 13F17M0121 Product Code PR-35541-HPHNL: 13F17F0219 13F17H0523 Product Code PR-35541-HPHNM: 13F17A0110 13F17B0046 13F17B0161 13F17C0353 13F17F0652 Product Code PR-35552-HPHNL: 13F17B0322 13F17J0008 Product Code PR-35552-HPHNM: 13F17B0109 13F17B0318 13F17F0245

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2023-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Arrow International Inc

  • Z-2380-2026 Class I — Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 (Apr 21, 2026)
  • Z-2364-2026 Class I — Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1… (Apr 21, 2026)
  • Z-2383-2026 Class I — Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU (Apr 21, 2026)
  • Z-2372-2026 Class I — Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A (Apr 21, 2026)
  • Z-2396-2026 Class I — Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20… (Apr 21, 2026)
  • Z-2368-2026 Class I — Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA… (Apr 21, 2026)
  • Z-2367-2026 Class I — Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA… (Apr 21, 2026)
  • Z-2365-2026 Class I — Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC… (Apr 21, 2026)
  • Z-2382-2026 Class I — Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE… (Apr 21, 2026)
  • Z-2371-2026 Class I — Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL… (Apr 21, 2026)

FDA data resources