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Ambler Surgical
AMBLER SURGICAL CORP. · Model Bimanual irrigation tip · UDI-DI 00190660087883
KYG
Prescription
10
510(k) clearances
2,140
Adverse events
11
Recalls
83
Facilities
Description
Bimanual irrigation tip, 20 gauge, Connor wand, curved shaft, two 0.5mm irrigation ports facing left and right, for use with Ambler # 7600E
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.