Recall Z-0435-2016
Summit Medical, Inc. · initiated September 3, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 160889, 161354
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.
FDA-determined cause: Process control
Action taken
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 ndove@summitmedicalusa.com.
Details
- Recall number
- Z-0435-2016
- Initiated
- September 3, 2015
- Terminated
- May 2, 2016
- Product code
- LRD – Applicator, Ent Drug
- Quantity
- 9 boxes (10 /box)
- Distribution
- Distributed to CA.
- Recalling firm
- Summit Medical, Inc., Eagan, MN