CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Femoral Artery Pressure Monitoring Set recalled by Cook
Cook is recalling Femoral Artery Pressure Monitoring Set, distributed nationwide in the US. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class II.
Check your package
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-0966-2018
- FDA event ID
- 79195
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2017
- FDA classified
- 9 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 13 Oct 2017 | Recall initiated by company | |
| 9 Mar 2018 | Classified by FDA | +147 days |
| 21 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label does not state that the product is heparin-coated.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Femoral Artery Pressure Monitoring Set
Where it was distributed
Nationally
Questions about this recall
Is Femoral Artery Pressure Monitoring Set recalled?
Yes. Cook recalled Femoral Artery Pressure Monitoring Set on 13 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0966-2018.
Why was it recalled?
Label does not state that the product is heparin-coated.
Which lots are affected?
Catalog # C-PMS-300-CHILDRENS-A- 032988 ALL LOTS
Where was it sold?
Nationally
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.
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |