Recall Z-1427-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated February 23, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Centurion STERILE TRACH BRUSH, Product Code 6225ST
Codes / lots: UDI/DI 50653160004750 (case), 00653160004755 (each), Lot Numbers: 2023021090
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
FDA-determined cause: Process control
Action taken
Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
Details
- Recall number
- Z-1427-2024
- Initiated
- February 23, 2024
- Posted by FDA
- March 29, 2024
- Product code
- EPE – Brush, Cleaning, Tracheal Tube
- Quantity
- 1700
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1428-2024 Class II | Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1429-2024 Class II | Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1430-2024 Class II | Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430STProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1431-2024 Class II | Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1432-2024 Class II | Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1433-2024 Class II | Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1434-2024 Class II | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1435-2024 Class II | Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1436-2024 Class II | Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1437-2024 Class II | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1438-2024 Class II | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1439-2024 Class II | Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1440-2024 Class II | Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1441-2024 Class II | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256)…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1442-2024 Class II | Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246)…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1443-2024 Class II | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1444-2024 Class II | Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031)…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1445-2024 Class II | Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1446-2024 Class II | Centurion STERILE #16 RUBBER BAND, Product Code EB16Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1447-2024 Class II | Centurion PICC LINE SECUREMENT KIT, Product Code IVS565Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1448-2024 Class II | Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1449-2024 Class II | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1450-2024 Class II | Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1451-2024 Class II | Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1452-2024 Class II | MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582AProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1453-2024 Class II | MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1454-2024 Class II | MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |
| Z-1455-2024 Class II | MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | 02/23/2024Open, Classified |