Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82070

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
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

2 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 2

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Z-1118-2019
Recall number
Z-1118-2019
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
None (US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Code information

Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153

Distribution pattern

FL, NC

device · product 2 of 2

Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396

Z-1119-2019
Recall number
Z-1119-2019
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
45 eaches total (US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Code information

Lot Numbers: US: 71F15J1055 71F15K0223 71F15D1461 71F18A1856 Worldwide: 71F14H0908 71F15K0223 71F16M1878 71F18A0343 71F14J0958 71F15L0155 71F17A0524 71F18A1856 71F14J1954 71F15L1514 71F17A1118 71F18B0295 71F14J1955 71F15M0771 71F17A1119 71F18B3053 71F14K1117 71F16A0286 71F17A2452 71F18C0752 71F14L0040 71F16A1142 71F17C0184 71F18C1686 71F14L0813 71F16B0097 71F17C0408 71F18C2250 71F14M0892 71F16B1126 71F17C2294 71F18C3030 71F14M1389 71F16B2212 71F17C2749 71F18C3042 71F15A0039 71F16C1127 71F17D0329 71F18D2222 71F15D1461 71F16D1063 71F17E1237 71F18E1357 71F15E1320 71F16E0976 71F17E2316 71F18E1753 71F15F1005 71F16F0403 71F17F0829 71F18F2625 71F15F1955 71F16F1512 71F17G1171 71F18G0263 71F15G0461 71F16G0246 71F17G1628 71F18G2183 71F15G1764 71F16H0027 71F17H2043 71F18H0650 71F15H0569 71F16H0595 71F17J0668 71F18H1673 71F15H1347 71F16L0623 71F17L1848 71F18J0116 71F15J0063 71F16L1734 71F17M1416 71F15J1055 71F16M0795 71F17M1978

Distribution pattern

FL, NC