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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85605

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

Open FDA event record

Event summary

Timeline bucket
April 30, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook 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

Pressure Monitoring Set, C-PMS, G02838

Z-2203-2020
Recall number
Z-2203-2020
Initiated
April 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
6792

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

Code information

Lot Numbers: 8910219, 8937938, 8951879, 8979177, 8990088, 9007566, 9008052, 9039794, 9351985, 9351986, 9354853, 9359896, 9367663, 9372621, 9380316, 9381545, 9386056, 9386351, 9389523, 9395471, 9395682, 9395683, 9402026, 9403779, 9406107, 9409058, 9412543, 9414585, 9416780, 9486988, 9785433, 9799632, 9799638, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9880405, 9889391, 9892371, 9898730, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 10109034, 10111785, 10130377, 10130378, 10134000, 10148417, NS8927417

Distribution pattern

Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia

device · product 2 of 2

Pressure Monitoring Tray, C-PMSY, G02854

Z-2204-2020
Recall number
Z-2204-2020
Initiated
April 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
1899

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

Code information

Lot Numbers: 9402033, 9406111, 9782916, 9789983, 9824026 ***Added 7/7/20*** 9829655, 9850622, 9864806, 9874004, 9880413, 9904717, 9910200, 9922162, 9934864, 9954321, 9961179, 10133951, 10142269, 10145133

Distribution pattern

Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia