FDA Enforcement
Class II
Terminated
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.
Recall: Z-0435-2016
·
Reported December 23, 2015
Enforcement
- Recall Number
- Z-0435-2016
- Event ID
- 72276
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Summit Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 23, 2015
- Initiation Date
- September 3, 2015
- Classification Date
- December 16, 2015
- Termination Date
- May 2, 2016
- Address
- 815 Northwest Pkwy Ste 100, N/A, Eagan, MN, 55121-1658, United States
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
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 Info
160889, 161354
Distribution
Distributed to CA.
Quantity
9 boxes (10 /box)