CooperSurgical, Inc. 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0502-2024
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during… Recall
Issued December 13, 2023 · CooperSurgical, Inc.
In December 2023, CooperSurgical, Inc. recalled the Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CooperSurgical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CooperSurgical, Inc.
- Category
- Health
- Recall date
- December 13, 2023
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
- Recall number
- FDA-Z-0502-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- CooperSurgical, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.