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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85776

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

Open FDA event record

Event summary

Timeline bucket
May 27, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Prodimed Plastimed Division

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

6 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 6

Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US

Z-2487-2020
Recall number
Z-2487-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
7220

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide

device · product 2 of 6

Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US

Z-2488-2020
Recall number
Z-2488-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
39800

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide

device · product 3 of 6

Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US

Z-2489-2020
Recall number
Z-2489-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide

device · product 4 of 6

Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19

Z-2490-2020
Recall number
Z-2490-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
1460

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide

device · product 5 of 6

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US

Z-2491-2020
Recall number
Z-2491-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
180

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide

device · product 6 of 6

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19

Z-2492-2020
Recall number
Z-2492-2020
Initiated
May 27, 2020
Classification
Class II
Status
Terminated
Quantity
2580

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

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

Lack of assurance of sterility

Code information

All lots within expiry

Distribution pattern

Nationwide