Severity
Moderate
FDA Devices recall · Reported December 21, 2016
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. Potenti…
Cook Inc. recalled Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray … - a moderate-severity action.
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray … was recalled by Cook Inc. in December 21, 2016. Reason: Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could res…. Check the official notice for the remedy. Verify recall #Z-0733-2017 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could res….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0733-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0733-2017) was formally reported on December 21, 2016, with the manufacturer initiating the action on November 28, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 99 units.
The documented reason for this recall is: 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 re… Distribution data in the federal record shows the product reached: AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
99 units
Related Recalls
6
3 from same agency
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0733-2017 |
| Date reported | December 21, 2016 |
| Date initiated | November 28, 2016 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 99 units |
| Distribution | AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 21, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.