CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Prodimed Combicath catheters recalled by Prodimed Plastimed Division

Prodimed Plastimed Division is recalling Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-Combicath PE Product, distributed nationwide in the US. The recall was initiated on 27 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry

Quantity recalled7220

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2487-2020
FDA event ID: 85776
Recalling firm: Prodimed Plastimed Division, Le Plessis Bouchard
Classification: Class II
Status: Terminated
Recall initiated: 27 May 2020
FDA classified: 4 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

27 May 2020	Recall initiated by company
4 Jul 2020	Classified by FDA	+38 days
15 Jul 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-Combicath PE Product recalled?

Yes. Prodimed Plastimed Division recalled Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-Combicath PE Product on 27 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2487-2020.

Why was it recalled?

Lack of assurance of sterility

Which lots are affected?

All lots within expiry

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Prodimed Plastimed Division

All 6

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020Device	CLASS II	Prodimed Combicath catheters recalled by Prodimed Plastimed Division	Prodimed Plastimed Division	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Prodimed Combicath Paediatric catheters recalled	Prodimed Plastimed Division	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Prodimed Combicath catheters recalled by Prodimed Plastimed Division	Prodimed Plastimed Division	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Prodimed Combicath Paediatric catheters recalled	Prodimed Plastimed Division	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Prodimed Combicath catheters recalled by Prodimed Plastimed Division	Prodimed Plastimed Division	Sterility	Nationwide

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide