Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90393

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

Open FDA event record

Event summary

Timeline bucket
May 25, 2022
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Cook Incorporated

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

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Z-1362-2022
Recall number
Z-1362-2022
Initiated
May 25, 2022
Classification
Class II
Status
Completed
Recalling firm
Cook Incorporated
Quantity
11,451 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate

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

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

Code information

UDI-DI: (01)00827002028388; Lot Numbers: 9665716, 9679942, 9686540, 9686549, 9689250, 9689343, 9692548, 9692549, 9699716, 9699717, 9705738, 9709183, 9712150, 9712373, 9736455, 9742510, 9746575, 9746716, 9760404, 9760475, 9766121, 9775119, 9780326, 9782923, 9785433, 9792467, 9793490, 9799632, 9799638, 9804929, 9824019, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9889391, 9892371, 9895593, 9898132, 9898730, 9902290, 9902927, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938186, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 9976722, 9978990, 9880405, 9981888, 9999793, 9999803, 10003519, 10005927, 10009215, 10009245, 10024184, 10024217, 10024218, 10032460, 10035628, 10035750, 10044472, 10044906, 10051940, 10055076, 10108943, 10109034, 10111785, 10117980, 10121837, 10121846, 10127381, 10127456, 10130377, 10130378, 10133950, 10133956, 10133957, 10133961, 10134000, 10142279, 10145130, 10148417, 10148426, 10148473, 10148591, 10148632, 10161897, 10161961, 10164500, 10164506, 10169956, 10169957, 10190606, 10190623, 10190633, 10190677, 10195251, 10197815, 10197831, 10200912, 10200913, 10207095, 10209858, 10220200, 10220208, 10222904, 10222926, 10226192, 10229970, 10229997, 10229998, 10236738, 10243510, 10243516, 10245424, 10247563, 10251181, 10266211, 10269457, 10327125, 10327126, 10327131, 10327133, 10327134, 10327136, 10328195, 10328201, 10328210, 10331628, 13004566, 13018910, 9874017X, 9875796X, NS9880393

Distribution pattern

US Nationwide. Brazil, Canada,

Field note

Send feedback

We'll only use this to respond to your feedback.