CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report
AbsorbENT, Sterile Compressed Absorbent Sponge recalled
Summit Medical is recalling AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack(L) (W) (H), RH-7413-10, distributed in California. The recall was initiated on 3 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0435-2016
- FDA event ID
- 72276
- Recalling firm
- Summit Medical, Eagan, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2015
- FDA classified
- 16 Dec 2015
- Reported
- 23 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2015 | Recall initiated by company | |
| 16 Dec 2015 | Classified by FDA | +104 days |
| 23 Dec 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distributed to CA.
Questions about this recall
Is AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack(L) (W) (H), RH-7413-10 recalled?
Yes. Summit Medical recalled AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack(L) (W) (H), RH-7413-10 on 3 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0435-2016.
Why was it recalled?
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.
Which lots are affected?
160889, 161354
Where was it sold?
Distributed to CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Summit Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Nasal Septal Button, Medium recalled by Summit Medical | Summit Medical | Sterility | 6 states |
| Device | CLASS II | Armstrong Grommet with wire Otological Ventilation Tube recalled | Summit Medical | Sterility | CA |
| Device | CLASS II | BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P recalled | Summit Medical | Sterility | 4 states |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |