B BRAUN L7500 Lactated Ringer’s Injection User Guide
- June 1, 2024
- B BRAUN
Table of Contents
B BRAUN L7500 Lactated Ringer’s Injection User Guide
URGENT PHARMACEUTICAL RECALL NOTIFICATION
Lactated Ringer’s Injection USP 1L EXCEL® IV CONTAINER
Dear Valued Customer:
The purpose of this letter is to inform you that B. Braun Medical Inc. (BBMI)
is issuing a voluntary pharmaceutical recall for product Lactated Ringer’s
Injection USP 1L, L7500, due to the potential for the container to leak when
high stresses are applied during shipping and handling.
Affected Product and Distribution Information:
Product Catalogue Number| NDC Number| Product Description|
Lot Number| Distribution Range| Expiration Date| Region
Distributed
---|---|---|---|---|---|---
L7500| 0264-7750-00| LAC RNG INJ 1L| J3N023| 28.Dec.2023-11.Jan.2024|
31.MAR.2026| United States
The depth of this voluntary recall is to the user/consumer level. This recall is being conducted with the knowledge of the United States Food & Drug Administration. A copy of the product label is provided in attachment 1 for your reference.
Reason for the recall:
Item L7500, Batch: J3N023 was inadvertently released to the market. The
product did not meet specifications for cylindrical burst testing and was not
intended for distribution. Failure of cylindrical burst testing may be
indicative of potential leakage concerns during distribution and handling of
the product.
Risk to Health:
To date, there have been no customer complaints received and there have been
no reports of serious injury or death associated with this issue. Unidentified
leakage could lead to contamination with microorganisms causing the potential
for bloodstream infection from product usage which could become a life-
threatening event.
Actions Required by B. Braun Medical Inc. (BBMI) Customer/User:
- Review the Pharmaceutical Recall Notification in its entirety and ensure that all users in your organisation of the above-mentioned product, and other concerned persons are informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the consumer level.
- Determine your current inventory of the affected items within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product.
- Utilising the attached “Pharmaceutical Recall Acknowledgement Form”, record the total number of individual impacted units. If you have no inventory remaining, please enter zero (0) on the form.
- Return the completed “Pharmaceutical Recall Acknowledgement Form” to B. Braun Medical Inc. Quality Assurance department by faxing the form to 610-849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
- Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.
reported to BBMI’s Post market Surveillance Department by calling 1-833-425-1464. They may also be reported to the FDA’s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
We apologize for the inconvenience that this issue may have caused you and your facility, and we appreciate your understanding of our commitment to assuring our products are safe and effective for both health care professionals and patients.
Sincerely
Electronically signed by : Cynthia Bauer Reason: For the reason(s)
specified in the document.
Date: Mar 22, 2024 10:06 EDT
Cynthia Bauer
Manager II, Customer Complaint Advocacy & Recalls Post market Surveillance
B. Brain Medical Inc.
Enclosures:
Pharmaceutical Recall Acknowledgement Form
Notes:
- URL for reporting online: https://www.fda.gov/safety/medwatch-fdo-safety-information-and-adverse-event-reporting-program/reporting- serious-problems-fda
- URL for Downloadable Form: https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fdo-safety-reporting
Attachment 1 Sample Product Label
Documents / Resources
| B
BRAUN L7500 Lactated Ringer's
Injection
[pdf] User Guide
L7500, L7500 Lactated Ringer s Injection, Lactated Ringer s Injection, Ringer
s Injection, Injection
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