AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
FDA Recall Z-0435-2016 · Posted None
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Recalling FirmSummit Medical, Inc.
Recall StatusTerminated
Product CodeLRD
Date Initiated2015-09-03
Date Terminated2016-05-02
Product Quantity9 boxes (10 /box)
Reason for Recall
Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.
Firm Action
Consignees were sent a Summit Medical "Medical Device Recall" letter, dated September 2, 2015. The letter described the problem and the product involved in the recall. It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product. For questions, contact Nicole Dove at 651-789-3921 or [email protected].
Root Cause
Process control
Distribution Pattern
Distributed to CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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