Recall Z-0435-2016— Summit Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Summit Medical, Inc., initiated 2015-09-03, terminated 2016-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Summit Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-03
- Terminated
- 2016-05-02
- Firm location
- Eagan, MN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.