CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report
Spectrum Minocycline/Rifampin Impregnated Double Lumen recalled by Cook
Cook is recalling Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook, distributed in 15 states. The recall was initiated on 28 Nov 2016 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-0733-2017
- FDA event ID
- 75793
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Nov 2016
- FDA classified
- 12 Dec 2016
- Reported
- 21 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 Nov 2016 | Recall initiated by company | |
| 12 Dec 2016 | Classified by FDA | +14 days |
| 21 Dec 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
Product as listed by the FDA
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
Where it was distributed
AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
ArizonaCaliforniaDistrict of ColumbiaGeorgiaIllinoisLouisianaMinnesotaMississippiNorth CarolinaNevadaNew YorkPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
Which lots are affected?
catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835 Exp date 9/30/2018
Where was it sold?
AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
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.
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |