CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

H/S Catheter SET FR 5 with Integated Stylet recalled by CooperSurgical

CooperSurgical is recalling H/S Catheter SET FR 5 with Integated Stylet, distributed nationwide in the US. The recall was initiated on 31 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 60888937016453 S/N: 309967

Quantity recalled90 units

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-0504-2024
FDA event ID: 93239
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Ongoing
Recall initiated: 31 Mar 2022
FDA classified: 6 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

31 Mar 2022	Recall initiated by company
6 Dec 2023	Classified by FDA	+615 days
13 Dec 2023	Published in enforcement report	+7 days

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

Reason for recall

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

Where it was distributed

Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

Nationwide

Questions about this recall

Why was it recalled?

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

Which lots are affected?

UDI-DI: 60888937016453 S/N: 309967

Where was it sold?

Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

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

Other products in this recall event

2 other products · FDA event 93239

This product is part of a recall event; the main page for the event is Cooper Surgical H/S Elliptosphere Cath -For administering recalled.

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023	CLASS II	Cooper Surgical H/S Elliptosphere Cath -For administering recalled	CooperSurgical	Packaging Defects	Nationwide
13 Dec 2023	CLASS II	Cooper Surgical H/S Elliptosphere Cath Set recalled	CooperSurgical	Packaging Defects	Nationwide

More recalls from CooperSurgical

All 86

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