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Ambler Surgical
AMBLER SURGICAL CORP. · Model Bimanual irrigation unibody handpiece · UDI-DI 00190660205751
KYG
Prescription
10
510(k) clearances
2,134
Adverse events
11
Recalls
82
Facilities
Description
Bimanual irrigation unibody handpiece, 4'', 23 gauge, curved shaft, dual 0.3mm aspiration port, titanium
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | B. Braun Medical, Inc. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and heal |
| 2010-05-12 | Insight Instruments, Inc. | Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Pr |
| 2010-05-12 | Insight Instruments, Inc. | Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. P |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-03-02 | Becton Dickinson and Company | Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm) |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign de |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.