Summit Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0435-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
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.
Product Classification:
Class II
Date Initiated: September 3, 2015
Date Posted: December 23, 2015
Recall Number: Z-0435-2016
Event ID: 72276
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.
Status: Terminated
Product Quantity: 9 boxes (10 /box)
Code Information:
160889, 161354
Distribution Pattern:
Distributed to CA.
Voluntary or Mandated:
Voluntary: Firm initiated