Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA22…
MEDLINE INDUSTRIES, LP - Northfield · Trumpet Needle Guide ring can detach when excessive pressure is applied.
Open FDA's page for this record- Cfres ID
- 207232
- Product res number
- Z-1918-2024
- Event date initiated
- 2024-03-01
- Event date posted
- 2024-05-29
- Recall status
- Open, Classified
- Res event number
- 94448
- Product code
- OJH
- Firm FEI number
- 1417592
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Address 1
- 3 Lakes Dr
- City
- Northfield
- State
- IL
- Postal code
- 60093-2753
- Additional info contact
- Karin Johnson 886-359-1704
- Reason for recall
- Trumpet Needle Guide ring can detach when excessive pressure is applied.
- Root cause description
- Process control
- Product quantity
- 12994 units
- Distribution pattern
- US Nationwide distribution.
- Product description
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray
- Code info
a) DYNDH1832: UDI/DI 40195327330713 (case), 10195327330712 (unit), Lot Numbers: 23KBI682, 23KBT359, 23KBX629; b) DYNJRA2210: UDI/DI 40195327424047 (case), 10195327424046 (unit), Lot Numbers: 23JBX245, 23LBN930; c) DYNJRA9046: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23JBX368, 23JBX369, 23JBX370, 23LBA896, 23LBH751, 23LBL612, 23LBV325, 23LBV326; d) DYNJRA9046H: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23LBL612, 23LBV325;
- Action
Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.
- Harmonized identifiers (openFDA)
- Device name
- Orthopedic Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4800
- Device class
- 1
- Registration number
- 3008864603, 1043534, 3008544874, 1061124, 3018077422, 1835444, 3025346039, 3008111820, 1030451, 3014554088, 3004111573, 1020279, 3009546990, 1424263, 3008534770, 3009203853, 3005595283, 3010667733, 3014680744, 3015131017, 3006981798, 3011187779, 3015543569, 1423395, 1221053, 3010052483, 1417592, 3004122598, 3009888344, 1047429, 3008395366, 3015173212, 1928237, 3007329020, 1643817, 3014170143, 3017823294, 1825034, 2029015, 3007663067 +20 more
- FEI number
- 3008864603, 1043534, 3008544874, 3025346039, 3018077422, 3002807830, 3008111820, 1030451, 3014554088, 3003407235, 3004111573, 3009546990, 1020279, 3008534770, 3009203853, 3005595283, 3010667733, 3014680744, 3002902735, 3000717687, 3015131017, 3006981798, 3011187779, 3015543569, 1221053, 3010052483, 1417592, 3004122598, 3003015552, 3009888344, 1047429, 3008395366, 3015173212, 1928237, 3007329020, 1643817, 3014170143, 3017823294, 3001236905, 1825034 +20 more