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Class I: serious health riskTerminated

Baxter Healthcare 0.9 % Sodium Chloride Injection Recall

0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Heal…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class I
Reported by FDA
Aug 27, 2014
Recall ID
D-1550-2014
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9 % Sodium Chloride Injection starting May 12, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-1550-2014 on Aug 27, 2014. Reason: Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes. Status: Terminated.

Why it was recalled

Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes

Product description

0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015

Lot numbers, UPCs & expiration codes

Lot C931923, exp 8/31/2015

Where it was sold

Nationwide

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-1550-2014
Classification
Class I
Status
Terminated
Recall initiated
May 12, 2014
FDA report date
Aug 27, 2014
Quantity
4,200 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1550-2014, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
68089
Address
1 Baxter Pkwy
Code information
Lot C931923, exp 8/31/2015
Postal code
60015-4625
Report date
Aug 27, 2014
Product type
Drugs
Recall number
D-1550-2014
Classification
Class I
Recalling firm
Baxter Healthcare Corp.
Product quantity
4,200 containers
Termination date
Jun 29, 2015
Reason for recall
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Distribution pattern
Nationwide
Recall initiation date
May 12, 2014
Initial firm notification
Letter
Center classification date
Aug 21, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1550-2014, published Aug 27, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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