Custom Sterile and Non-Sterile Procedural Kits recall: Sterility Concern
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;
Why was Custom Sterile and Non-Sterile Procedural Kits recalled?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ33638J, UPC Number: 019348956435. b. Model Number: DYNJRA1543, UPC Number: 019348921766. c. Model Number: DYNJRA1247, UPC Number: 019348950391. d. Model Number: DYNJ42367B, UPC Number: 019348921151. e. Model Number: DYNJRA1739, UPC Number: 019348926312. f. Model Number: DYNJ0134147D, UPC Number: 088994293734. g. Model Number: DYNJRA1220, UPC Number: 088827779503; Model Number: DYNJRA1571, UPC Number 019348926473. h. Model Number: DYNJRA1109A, UPC Number: 019348925132. i. Model Number: DYNJRA0656A, UPC Number: 088994222511; Model Number: DYNJRA1287A, UPC Number: 019348977309; Model Number: DYNJRA1604, UPC Number 019348929981. j. Model Number: DYNJRA0725, UPC Number: 019348926312. k. Model Number: DYNJ51107B, UPC Number: 019348981047. l. Model Number: DYNJRA1773, UPC Number: 019348986297. m. Model Number: PAIN1622A, UPC Number: 019348989169. n. Model Number: DYNJRA1635A, UPC Number: 019348936764.
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 29,126 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)