Why it was recalled
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Product description
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
Lot numbers, UPCs & expiration codes
Lot # HS05A266E , size "E" and "D", NDC # 11054-009-XX Number and Part Numbers = USPE, USPEAC, USPDAC
Where it was sold
To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.
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-386-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 10, 2013
- FDA report date
- Jan 1, 2014
- Quantity
- 145 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Airgas Medical Services
Original FDA data
Every field from FDA enforcement report D-386-2014, exactly as published.
Show all FDA fields
- City
- Radnor
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66695
- Address
- 259 N Radnor Chester Rd
- Address (line 2)
- St # 100
- Code information
- Lot # HS05A266E , size "E" and "D", NDC # 11054-009-XX Number and Part Numbers = USPE, USPEAC, USPDAC
- Postal code
- 19087-5240
- Report date
- Jan 1, 2014
- Product type
- Drugs
- Recall number
- D-386-2014
- Classification
- Class II
- Recalling firm
- Airgas Medical Services
- Product quantity
- 145 cylinders
- Termination date
- Sep 3, 2014
- Reason for recall
- Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
- Distribution pattern
- To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.
- Recall initiation date
- Oct 10, 2013
- Initial firm notification
- Telephone
- Center classification date
- Dec 23, 2013