Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactur
FDA device recall Z-0346-04 · posted 2004-01-14 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
- Action taken
- The firm contacted their consignees on 12/11/2003 by telephone and letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- HMX
- Quantity affected
- 110 vials
- Distribution
- The product was distributed to customers in OH and PA.
- Date initiated
- 2003-12-11
- Date posted
- 2004-01-14
- Date terminated
- 2004-04-08
- Location
- Groveport, OH
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