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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84560

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

Open FDA event record

Event summary

Timeline bucket
December 27, 2019
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

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

Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

Z-0815-2020
Recall number
Z-0815-2020
Initiated
December 27, 2019
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
1604

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

Code information

9799196 9909433 9909435 NS9915808 9796032 9797075 9803175 9806067 9903048 9904465 9904469 9908750 9912303 9916724 9785599 9785601 9791159 9796027 9813313 9824161 9825417 9828101 9828889 9830401 9830764 9833563 9836323 9839119 9844952 9846005 9846008 9913052 9915805 9791163X 9792493X NS9813314 NS9828892 NS9834712

Distribution pattern

Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom.