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B. BRAUN PRODUCT INFORMATION NOTICE: SODIUM CHLORIDE INJECTION

B. BRAUN MEDICAL INC. HAS ISSUED A PRODUCT INFORMATION NOTICE REGARDING CERTAIN LOTS OF 0.9% SODIUM CHLORIDE INJECTION, USP IN THE EXCEL PLUS CONTAINER (1000 ML AND 500 ML) WITH PRIMARY AIR VOLUME (HEADSPACE) BELOW SPECIFICATION LIMITS. THIS TECHNICAL VARIANCE COULD POTENTIALLY IMPACT CONTAINER FLUID LEVEL MONITORING DURING USE.

REUPLOADED

Notice Date: December 10, 2024
Notice Type: Product Information
Status: No Action Required for MedAire Clients

Overview

B. Braun Medical Inc. has issued a product information notice regarding certain lots of 0.9% Sodium Chloride Injection, USP in the EXCEL Plus container (1000 mL and 500 mL) with primary air volume (headspace) below specification limits. This technical variance could potentially impact container fluid level monitoring during use.

MedAire Client Impact

No action is required for MedAire clients. The affected batch referenced in this notice is from a past production period. All medical kits currently shipping from MedAire facilities and all future refurbishments are not affected by this issue.

While these affected lots may exist in some operational systems from prior distributions, any kits leaving MedAire facilities today and moving forward do not contain products from the impacted batches.

Affected Products

The following twelve (12) lots are affected by this notice:

Product Code NDC Description Lot Number Expiration Date
Q8000 0264-5802-00 0.9% Sodium Chloride USP in EXCEL Plus container, 1000 mL 0061903616 February 28, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913818 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913823 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913825 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913826 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913829 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061913832 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061917427 May 31, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061917428 May 31, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061918912 April 30, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061929714 August 31, 2026
Q8001 0264-5802-10 0.9% Sodium Chloride USP in EXCEL Plus container, 500 mL 0061929744 August 31, 2026

Technical Details

Primary Air Volume (Headspace) Specification Variance:
During manufacturing, EXCEL Plus products receive a small amount of air (primary air volume or "headspace") to ensure solution flows evenly and completely during use. The twelve lots listed above tested below the lower specification limit of 30 cubic centimeters (cc) in finished goods testing, though all lots were within specification during in-process testing.

Potential Impact:
When measuring remaining solution volume using the bag's graduation marks, measurement error may be as great as 30% at nominal headspace volumes. The label's graduation marks should not be used for dosage determinations. This measurement consideration is typical for products within specification and is not unique to these specific batches.

Manufacturer Recommendations

While no significant impact to flow rate or delivered volume is expected, B. Braun Medical Inc. recommends the following:

  • If inadequate flow rate or insufficient delivered volume is experienced, report the issue as a customer complaint to B. Braun following the instructions below
  • Do not use label graduation marks for dosage determinations

Reporting and Contact Information

For Quality Issues or Adverse Events:

  • B. Braun Customer Service: 1-833-425-1464
  • B. Braun Medical Affairs Department: 1-800-854-6851

Report to FDA MedWatch:

  • Online: www.fda.gov/medwatch/report.htm
  • Phone: 1-800-332-1088
  • Fax: 1-800-FDA-0178 (1-800-332-0178)

Direct Manufacturer Contact:

  • Email: recalls@bbraunusa.com
  • Phone: (844) 903-6412
  • Fax: (810) 849-1197

Additional Information

For complete prescribing information and additional technical details, please contact B. Braun Medical Inc. directly or refer to the full product information notice from the manufacturer.

Questions about MedAire kits or refurbishment services? Contact your MedAire representative or our customer service team for assistance.

Attachment: BB Braun Sodium Chloride product notice.pdf