Z-3265-2018Class II
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper
Bausch & Lomb Incorporated / initiated 2018-08-08 / Terminated / root cause: manufacturing process
Bausch & Lomb Inc began a recall of Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper on . FDA classified it as Class II and gives the reason as "The back cap separates from the body of the vitrectomy cutter". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-3265-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Bausch & Lomb Incorporated
- Product
- Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Product code
- HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Reason for recall
- The back cap separates from the body of the vitrectomy cutter.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.
- Quantity in commerce
- 33 cases
- Distribution
- Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
- Product codes and lots
- Lot numbers V9400, exp. 11/6/2018; W1439, exp. 8/19/2019; and W1467, exp. 8/26/2019, UDI 00757770058891.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3265-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3266-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3267-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3268-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3269-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3270-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3271-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3272-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3273-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3274-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3275-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3276-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3277-2018 | Class II | Terminated | Voluntary: Firm initiated |
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