Z-0435-2016Class II

AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10...

Name: Z-0435-2016 AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10...
Creator: Summit Medical, Inc.
Published: 2015-09-03
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2015-09-03 / Terminated / root cause: manufacturing process

FDA source

Summit Medical, Inc. began a recall of 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... on 2015-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0435-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Posted: 2015-12-17
Terminated: 2016-05-02
Recalling firm: Summit Medical, LLC
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.
Product code: LRD Applicator, Ent Drug
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 9 boxes (10 /box)
Distribution: Distributed to CA.
Product codes and lots: 160889, 161354

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0435-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0435-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16

Product code LRD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)