Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Reason for recall: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Om Quantity: 10090 units Lot/code info: a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-053, A42221-076, A42221-077, A42221-078, A42221-079, A42221-080, A42221-081, A42221-082, A42221-083, A42221-084, A42221-085, A42619-011, A42619-012, A42619-013, A42619-014, A42619-015, A42619-016, A42619-017, A42619-018, A42619-019, A42619-020, A42619-021, A42619-022, A42619-023, A42619-024, A42619-025, A42619-026, A42619-027, A42619-028, A42619-029, A42619-030, A42619-031, A42619-032, A42619-033, A42619-034, A42619-035, A42619-036, A43231-127, A43231-128, A43286-011, A43286-012, A43286-013, A43286-014,
00613994961167, 00613994961143, 00643169122956, 00643169964839, 00643169122963
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.