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Recall Observatory FDA recall evidence

Device 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.

Z-0435-2016

September 03, 2015

Class II

Product summary

Firm
Summit Medical, Inc.
Event
Event 72276
Status
Terminated
Classification
Class II
Quantity
9 boxes (10 /box)
Official record key
device-enforcement:Z-0435-2016

Official wording

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.

Code information: 160889, 161354

Distribution pattern: Distributed to CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.