Date Initiated by Firm |
May 25, 2022 |
Date Posted |
August 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1617-2022 |
Recall Event ID |
90336 |
510(K)Number |
K024240
|
Product Classification |
Culture media, non-propagating transport - Product Code JSM
|
Product |
a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957
|
Code Information |
GTIN:
a. 00382903649518 EA; 30382903649519 PK; 50382903649513.
b. 00382903649532; 30382903649533; 50382903649537.
c. 00382903649570 EA; 50382903649575 CS
|
Recalling Firm/ Manufacturer |
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
|
For Additional Information Contact |
Ms. Ruby Upadhyaya 804-553-2281
|
Manufacturer Reason for Recall |
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
|
FDA Determined Cause 2 |
Environmental control |
Action |
Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle)
Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022.
Letter states:
If you have further distributed this product, please notify your patients at once of this product recall.
Your notification to your patients may be enhanced by including a copy of this recall notification letter.
¿ This recall should be carried out to the user level. Your assistance is appreciated and necessary to
prevent possible patient harm.
¿ Please complete and return the enclosed response form as soon as possible even if you do not have
any product on hand.
¿ Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
|
Quantity in Commerce |
a. 25 bx b. 53 bx c. 31 cs |
Distribution |
US Nationwide |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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