Recall Z-0346-04 ยท HMX Cannula, Ophthalmic
Cardinal Health
Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
| Date | Jan 14, 2004 (initiated Dec 11, 2003) |
| Status | Terminated |
| Reason | The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed. |
| Root cause | Other |
| Action | The firm contacted their consignees on 12/11/2003 by telephone and letter. |
| Quantity | 110 vials |
| Distribution | The product was distributed to customers in OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.