Home / Recalls / Summit Medical, Inc. / Z-0435-2016

Z-0435-2016 Class II Terminated

Recalled by Summit Medical, Inc. — Eagan, MN

FDA device recall Z-0435-2016 was initiated by Summit Medical, Inc. on Sep 3, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 2, 2016). Affected quantity: 9 boxes (10 /box).

Recall details

Product Type: Devices
Report Date: Dec 23, 2015
Initiation Date: Sep 3, 2015
Termination Date: May 2, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 boxes (10 /box)

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.

Distribution pattern

Distributed to CA.

Code information

160889, 161354

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0435-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.