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Class II: temporary or reversible health riskTerminated

Baxter Healthcare 0.9% Sodium Chloride Irrigation Recall

0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxte…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
May 7, 2014
Recall ID
D-1282-2014
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Irrigation starting Apr 21, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1282-2014 on May 7, 2014. Reason: Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.

Product description

0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.

Lot numbers, UPCs & expiration codes

Lot # Gl09272; Exp 09/16

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-1282-2014
Classification
Class II
Status
Terminated
Recall initiated
Apr 21, 2014
FDA report date
May 7, 2014
Quantity
211,752 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1282-2014, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
67974
Address
1 Baxter Pkwy
Code information
Lot # Gl09272; Exp 09/16
Postal code
60015-4625
Report date
May 7, 2014
Product type
Drugs
Recall number
D-1282-2014
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
211,752 bottles
Termination date
Feb 24, 2015
Reason for recall
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
Distribution pattern
nationwide
Recall initiation date
Apr 21, 2014
Initial firm notification
Letter
Center classification date
Apr 28, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1282-2014, published May 7, 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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