Z-0031-2016Class II
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft...
Resource Optimization & Innovation, LLC / initiated 2015-04-22 / Terminated / root cause: manufacturing process
Resource Optimization & Innovation Llc began a recall of regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI... on . FDA classified it as Class II and gives the reason as "The kits contain an equipment glove component which may contain splits or holes compromising the sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0031-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Resource Optimization & Innovation, LLC
- Product
- regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
- Product code
- FSY Light, Surgical, Ceiling Mounted
- Reason for recall
- The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- ROi initiated a recall of the custom kits via e-mail to their customers on April 22, 2015. The e-mail included their recall letter dated April 17, 2015. and the supplier's recall letter dated April 16, 2015. The customer was requested to discard the recalled component from their procedure tray at the time of set up and replace it with sterile stock. Customers were instructed to contact any ROi custom pack solutions manager with any concerns. The recalling firm issued a second e-mail notification on 10/19/2015 to the recall coordinator of the distributor. The notice informed them they had been receiving uncorrected product and reminded them to discard the defective component at the time the kit is set up for surgery. Any future distribution will be labeled with an alert to remove the defective component until the kits contain acceptable light handle covers. For questions regarding this recall call 314-364-6561.
- Quantity in commerce
- 600 kits
- Distribution
- Distribution was made to LA, MS, and TX.
- Product codes and lots
- Lot numbers 15003 and 17187.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0028-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0029-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0030-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0031-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0032-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0033-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0034-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0035-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0036-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0037-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0038-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0039-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0040-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0041-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0042-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0043-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0044-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0045-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0046-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0047-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0048-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0049-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0050-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0051-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0052-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0053-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0054-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0055-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0056-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0057-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0058-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0059-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0060-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0061-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0062-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0063-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0064-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0065-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0066-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0067-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0068-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0069-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0070-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0071-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0072-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0073-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0074-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0075-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0076-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0077-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0078-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0079-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0080-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0081-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0082-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0083-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0084-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0085-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0086-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0087-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0088-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0089-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0090-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0091-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0092-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0093-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0094-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0095-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0096-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0097-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0098-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0099-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0100-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0101-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0102-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0103-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0104-2016 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.