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Kirwan Surgical Products, LLC FDA Recalls
7 recalls on file across devices, 7 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable MicrosClass INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The DClass INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Class INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable MicroClass INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Class INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The DisClass INov 14, 2024Potential for the outer stainless-steel tube to break or det |
| Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The DisposabClass INov 14, 2024Potential for the outer stainless-steel tube to break or det |