Z-0456-03
0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Baxter Healthcare Corporation / initiated 2002-12-12 / Terminated / root cause: sterility
Baxter Healthcare Corp. began a recall of 0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case on . The reason FDA records is "Sterility questioned". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-0456-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Baxter Healthcare Corporation
- Product
- 0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
- Product code
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Reason for recall
- Sterility questioned
- Root cause tag
- sterility
- FDA root cause
- Other
- Action
- Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
- Quantity in commerce
- 51,052,140 syringes
- Distribution
- Nationwide, Canada, Honduras, Indonesia, Israel
- Product codes and lots
- all lots within expiration date of the following pre-filled syringes: Code 2K0901: 2 mL in 3 mL syringe Code 2K0903: 3 mL in 6 mL syringe Code K0905: 5 mL in 12 mL syringe Code 2K0906: 10 mL in 12 mL syringe Code 2K6011: 2 mL in 3 mL syringe w/cannula Code 2K6012: 3 mL in 6 mL syringe w/ cannula Code 2K6013: 5 mL in 12 mL syringe w/cannula Code 2K6014: 10 mL in 12 mL syringe w/cannula
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