Why it was recalled
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Product description
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Lot numbers, UPCs & expiration codes
Kit Part # 80-0211 - Kit Lot # 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit Lot # 80-0304041916; Kit Part # 80-0209 - Kit Lot # 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210 Kit Lot # 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit Lot # 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit Lot # 80-0301042916, 80-0301050316
Where it was sold
Nationwide, Australia & Switzerland
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0179-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2016
- FDA report date
- Dec 14, 2016
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- North American Rescue LLC.
Original FDA data
Every field from FDA enforcement report D-0179-2017, exactly as published.
Show all FDA fields
- City
- Greer
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 75415
- Address
- 35 Tedwall Ct
- Code information
- Kit Part # 80-0211 - Kit Lot # 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit Lot # 80-0304041916; Kit Part # 80-0209 - Kit Lot # 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210 Kit Lot # 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit Lot # 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit Lot # 80-0301042916, 80-0301050316
- Postal code
- 29650-4791
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0179-2017
- Classification
- Class II
- Recalling firm
- North American Rescue LLC.
- Product quantity
- unknown
- Termination date
- Mar 9, 2017
- Reason for recall
- Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
- Distribution pattern
- Nationwide, Australia & Switzerland
- Recall initiation date
- Sep 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2016